Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06467357




Registration number
NCT06467357
Ethics application status
Date submitted
21/05/2024
Date registered
21/06/2024
Date last updated
24/06/2025

Titles & IDs
Public title
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Scientific title
DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer
Secondary ID [1] 0 0
2023-508057-19-00
Secondary ID [2] 0 0
D781PC00001
Universal Trial Number (UTN)
Trial acronym
DESTINY-BTC01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Tract Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Durvalumab
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Rilvegostomig
Diagnosis / Prognosis - Agilent HercepTest™ mAb pharmDx
Diagnosis / Prognosis - Ventana PD-L1 SP263 assay

Experimental: Trastuzumab deruxtecan + rilvegostomig - Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm

Experimental: Trastuzumab deruxtecan - Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Active comparator: Standard of Care - Gemcitabine and cisplatin in combination with durvalumab arm


Treatment: Drugs: Gemcitabine
Standard of care chemotherapy by intravenous infusion

Treatment: Drugs: Cisplatin
Standard of care chemotherapy by intravenous infusion

Treatment: Drugs: Durvalumab
Standard of care immunotherapy by intravenous infusion

Treatment: Drugs: Trastuzumab deruxtecan
Experimental therapy by intravenous infusion

Treatment: Drugs: Rilvegostomig
Experimental therapy by intravenous infusion

Diagnosis / Prognosis: Agilent HercepTest™ mAb pharmDx
A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation.

Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis).

Diagnosis / Prognosis: Ventana PD-L1 SP263 assay
A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
Timepoint [1] 0 0
Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
Primary outcome [2] 0 0
Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population
Timepoint [2] 0 0
From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcome [1] 0 0
To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population
Timepoint [1] 0 0
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcome [2] 0 0
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
Timepoint [2] 0 0
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcome [3] 0 0
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population
Timepoint [3] 0 0
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcome [4] 0 0
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [4] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [5] 0 0
To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [5] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [6] 0 0
To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [6] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [7] 0 0
To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [7] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [8] 0 0
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [8] 0 0
From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
Secondary outcome [9] 0 0
To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [9] 0 0
From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
Secondary outcome [10] 0 0
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
Timepoint [10] 0 0
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcome [11] 0 0
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [11] 0 0
From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
Secondary outcome [12] 0 0
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [12] 0 0
From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
Secondary outcome [13] 0 0
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Timepoint [13] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [14] 0 0
To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care
Timepoint [14] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [15] 0 0
To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care
Timepoint [15] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [16] 0 0
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs
Timepoint [16] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [17] 0 0
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs
Timepoint [17] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [18] 0 0
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs
Timepoint [18] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [19] 0 0
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care
Timepoint [19] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [20] 0 0
To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care
Timepoint [20] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [21] 0 0
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy
Timepoint [21] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [22] 0 0
To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum
Timepoint [22] 0 0
From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig
Secondary outcome [23] 0 0
To investigate the immunogenicity of T-DXd and of rilvegostomig
Timepoint [23] 0 0
From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively
Secondary outcome [24] 0 0
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother
Timepoint [24] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [25] 0 0
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother
Timepoint [25] 0 0
Until End of Study (estimated up to 50 months)
Secondary outcome [26] 0 0
To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy
Timepoint [26] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
Secondary outcome [27] 0 0
To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother
Timepoint [27] 0 0
Until End of Study (estimated up to 50 months)

Eligibility
Key inclusion criteria
Key

* Participants must be = 18 years of age at the time of screening. Other age restrictions may apply as per local regulations;
* Male and female;
* Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
* histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC;
* Provision of FFPE tumor sample that is no older than 3 years;
* At least one target lesion assessed by the Investigator based on RECIST v1.1 (randomized portion only);
* WHO/ECOG performance status of 0 or 1;
* Adequate organ and bone marrow function within 14 days before randomization;
* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential;

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines;
* histologically confirmed ampullary carcinoma;
* history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions;
* spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
* medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke;
* Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment;
* active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening;
* Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG;
* History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder;
* Prior pneumonectomy (complete);
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
* Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant;
* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 6 months prior to randomization, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (only randomized portion).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/05/2029
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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California
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Florida
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Georgia
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Michigan
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Missouri
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Tennessee
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Texas
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Virginia
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Wiener Neustadt
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Austria
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Wien
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Belgium
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Anderlecht
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Belgium
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Edegem
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Belgium
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Gent
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Leuven
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Belgium
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Liège
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Roeselare
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Natal
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Santa Maria
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Nova Scotia
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Wuhan
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Xi'an
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Zhengzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Praha 10
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Czechia
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Praha 5
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Brest
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Clichy Cedex
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Bonn
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Dresden
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Frankfurt
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Freiburg
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Göttingen
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Hamburg
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Lübeck
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Munchen
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Germany
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Ulm
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Germany
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Wuerzburg
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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India
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Dehradun
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India
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Delhi
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India
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Kolkata
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India
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Mumbai
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India
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Vadodara
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India
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Varanasi
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Italy
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Firenze
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Italy
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Milano
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Italy
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Naples
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Tricase
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Hiroshima-shi
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Kanazawa
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Kashiwa
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Kawasaki-shi
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Japan
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Kita-gun
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Japan
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Kitaadachi-gun
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Japan
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Koto-ku
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Japan
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Kumamoto-shi
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Japan
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Kyoto-shi
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Japan
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Maebashi-shi
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Japan
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Mitaka-shi
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Japan
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Nagoya-shi
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Japan
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Osaka-shi
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Japan
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Osaka
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Japan
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Sakai-shi
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Japan
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Sapporo-shi
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Japan
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Sendai-shi
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Japan
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Shinjuku-ku
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Japan
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Suita-city
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Japan
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Sunto-gun
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Japan
State/province [132] 0 0
Ube-shi
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Japan
State/province [133] 0 0
Wakayama-shi
Country [134] 0 0
Japan
State/province [134] 0 0
Yokohama-shi
Country [135] 0 0
Korea, Republic of
State/province [135] 0 0
Busan
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Korea, Republic of
State/province [136] 0 0
Gyeonggi-do
Country [137] 0 0
Korea, Republic of
State/province [137] 0 0
Hwasun-gun
Country [138] 0 0
Korea, Republic of
State/province [138] 0 0
Seongnam-si
Country [139] 0 0
Korea, Republic of
State/province [139] 0 0
Seoul
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Malaysia
State/province [140] 0 0
George Town
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Malaysia
State/province [141] 0 0
Johor Bahru
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Malaysia
State/province [142] 0 0
Kuala Lumpur
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Malaysia
State/province [143] 0 0
Kuching
Country [144] 0 0
Netherlands
State/province [144] 0 0
Rotterdam
Country [145] 0 0
Philippines
State/province [145] 0 0
Cebu City
Country [146] 0 0
Philippines
State/province [146] 0 0
Makati
Country [147] 0 0
Philippines
State/province [147] 0 0
Pasig City
Country [148] 0 0
Philippines
State/province [148] 0 0
Quezon City
Country [149] 0 0
Poland
State/province [149] 0 0
Bialystok
Country [150] 0 0
Poland
State/province [150] 0 0
Katowice
Country [151] 0 0
Poland
State/province [151] 0 0
Kraków
Country [152] 0 0
Poland
State/province [152] 0 0
Lublin
Country [153] 0 0
Poland
State/province [153] 0 0
Warszawa
Country [154] 0 0
Poland
State/province [154] 0 0
Wroclaw
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Saudi Arabia
State/province [155] 0 0
Ar Riya?
Country [156] 0 0
Saudi Arabia
State/province [156] 0 0
Dammam
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Saudi Arabia
State/province [157] 0 0
Riyadh
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State/province [158] 0 0
Banska Bystrica
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Slovakia
State/province [159] 0 0
Bratislava
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Slovakia
State/province [160] 0 0
Kosice
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Slovakia
State/province [161] 0 0
Martin
Country [162] 0 0
Slovakia
State/province [162] 0 0
Trnava
Country [163] 0 0
Spain
State/province [163] 0 0
Barcelona
Country [164] 0 0
Spain
State/province [164] 0 0
Madrid
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Spain
State/province [165] 0 0
Málaga
Country [166] 0 0
Spain
State/province [166] 0 0
Santander
Country [167] 0 0
Taiwan
State/province [167] 0 0
Kaohsiung City
Country [168] 0 0
Taiwan
State/province [168] 0 0
Kaohsiung
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Taiwan
State/province [169] 0 0
Taichung
Country [170] 0 0
Taiwan
State/province [170] 0 0
Taipei 112
Country [171] 0 0
Taiwan
State/province [171] 0 0
Taipei
Country [172] 0 0
Taiwan
State/province [172] 0 0
Taoyuan
Country [173] 0 0
Thailand
State/province [173] 0 0
Bangkok
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Thailand
State/province [174] 0 0
Hat Yai
Country [175] 0 0
Thailand
State/province [175] 0 0
Khon Kaen
Country [176] 0 0
Thailand
State/province [176] 0 0
Muang
Country [177] 0 0
Thailand
State/province [177] 0 0
Mueang
Country [178] 0 0
Thailand
State/province [178] 0 0
Naimuang
Country [179] 0 0
Thailand
State/province [179] 0 0
Ongkharak
Country [180] 0 0
Thailand
State/province [180] 0 0
Sisaket
Country [181] 0 0
Turkey
State/province [181] 0 0
Altindag
Country [182] 0 0
Turkey
State/province [182] 0 0
Antalya
Country [183] 0 0
Turkey
State/province [183] 0 0
Istanbul
Country [184] 0 0
Turkey
State/province [184] 0 0
Izmir
Country [185] 0 0
Turkey
State/province [185] 0 0
Mezitli
Country [186] 0 0
Turkey
State/province [186] 0 0
Yakutiye
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Birmingham
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Dundee
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Glasgow
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Greater London
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Leeds
Country [192] 0 0
United Kingdom
State/province [192] 0 0
London
Country [193] 0 0
Vietnam
State/province [193] 0 0
Hanoi
Country [194] 0 0
Vietnam
State/province [194] 0 0
Ho Chi Minh city
Country [195] 0 0
Vietnam
State/province [195] 0 0
Ho Chi Minh City
Country [196] 0 0
Vietnam
State/province [196] 0 0
Ho Chi Minh
Country [197] 0 0
Vietnam
State/province [197] 0 0
Vinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06467357