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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06318273




Registration number
NCT06318273
Ethics application status
Date submitted
13/03/2024
Date registered
19/03/2024
Date last updated
20/08/2024

Titles & IDs
Public title
A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
M24-742
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-969

Experimental: Part 1: ABBV-969 Dose Escalation - Participants will receive escalating doses of ABBV-969.

Experimental: Part 2 A: ABBV-969 Dose Expansion - Participants will receive dose A of ABBV-969 from part 1.

Experimental: Part 2 B: ABBV-969 Dose Expansion - Participants will receive dose B of ABBV-969 from part 1.


Treatment: Drugs: ABBV-969
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to 3 Years
Primary outcome [2] 0 0
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
Timepoint [2] 0 0
Up to 3 Years
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of ABBV-969
Timepoint [1] 0 0
Up to 3 Years
Secondary outcome [2] 0 0
Time to Maximum Observed Concentration (Tmax) of ABBV-969
Timepoint [2] 0 0
Up to 3 Years
Secondary outcome [3] 0 0
Terminal Phase Elimination Half-Life (t1/2) of ABBV-969
Timepoint [3] 0 0
Up to 3 Years
Secondary outcome [4] 0 0
Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969
Timepoint [4] 0 0
Up to 3 Years
Secondary outcome [5] 0 0
Antidrug Antibody (ADA)
Timepoint [5] 0 0
Up to 3 Years
Secondary outcome [6] 0 0
Neutralizing Antibodies (nAbs)
Timepoint [6] 0 0
Up to 3 Years
Secondary outcome [7] 0 0
Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)
Timepoint [7] 0 0
Up to 2 Years

Eligibility
Key inclusion criteria
* Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
* Estimated life expectancy > 6 months.
* Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).
* Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug.
* Must have received at least one NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or have refused, or are intolerant to, or unable to get access to taxanes).
* Must have >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 days prior to beginning study therapy.
* Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
* Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
* Laboratory values meeting the criteria laid out in the protocol.
* QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no >= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
* History of other active malignancy, as laid out in the protocol.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan.
* History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
* History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
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
8/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital /ID# 264293 - Fitzroy
Recruitment hospital [2] 0 0
Ballarat Base Hospital /ID# 264294 - Ballarat
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Rhode Island
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Israel
State/province [7] 0 0
Tel-Aviv
Country [8] 0 0
Israel
State/province [8] 0 0
Haifa
Country [9] 0 0
Israel
State/province [9] 0 0
Jerusalem
Country [10] 0 0
Japan
State/province [10] 0 0
Kyoto
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo

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

Ethics approval
Ethics application status

Summary
Brief summary
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.

ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Trial website
https://clinicaltrials.gov/study/NCT06318273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06318273