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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04262466




Registration number
NCT04262466
Ethics application status
Date submitted
30/01/2020
Date registered
10/02/2020
Date last updated
26/10/2024

Titles & IDs
Public title
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Scientific title
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Secondary ID [1] 0 0
IMC-F106C-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Select Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brenetafusp
Treatment: Drugs - Brenetafusp and pembrolizumab
Treatment: Drugs - Brenetafusp and chemotherapy
Treatment: Drugs - Brenetafusp and monoclonal antibodies and chemotherapy
Treatment: Drugs - Brenetafusp and tebentafusp
Treatment: Drugs - Brenetafusp and bevacizumab
Treatment: Drugs - Brenetafusp and kinase inhibitors

Experimental: Brenetafusp Monotherapy - Participants receive brenetafusp.

Experimental: Brenetafusp and Anti-PD(L)1 Agent - Participants receive brenetafusp and pembrolizumab.

Experimental: Brenetafusp and Chemotherapy - Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.

Experimental: Brenetafusp and Targeted Therapy - Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.

Experimental: Brenetafusp and Multimodal Therapy - Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.


Treatment: Drugs: Brenetafusp
Brenetafusp IV infusions

Treatment: Drugs: Brenetafusp and pembrolizumab
Brenetafusp and pembrolizumab IV infusions

Treatment: Drugs: Brenetafusp and chemotherapy
Brenetafusp and chemotherapy IV infusions

Treatment: Drugs: Brenetafusp and monoclonal antibodies and chemotherapy
Brenetafusp and a monoclonal antibody therapy and chemotherapy

Treatment: Drugs: Brenetafusp and tebentafusp
Brenetafusp and tebentafusp IV infusions

Treatment: Drugs: Brenetafusp and bevacizumab
Brenetafusp and bevacizumab IV infusions

Treatment: Drugs: Brenetafusp and kinase inhibitors
Brenetafusp and oral kinase inhibitors
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Incidence of dose-limiting toxicity (DLT)s
Timepoint [1] 0 0
Up to ~28 days after each dose
Primary outcome [2] 0 0
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)
Timepoint [2] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [3] 0 0
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations
Timepoint [3] 0 0
Up to ~12 months
Primary outcome [4] 0 0
Phase 1: Number of participants with abnormal laboratory test results (hematology)
Timepoint [4] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [5] 0 0
Phase 1: Number of participants with abnormal laboratory test results (chemistry)
Timepoint [5] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [6] 0 0
Phase 1: Number of participants with abnormal laboratory test results (coagulation)
Timepoint [6] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [7] 0 0
Phase 1: Number of participants with abnormal urinalysis
Timepoint [7] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [8] 0 0
Phase 1: Number of participants with abnormal vital signs
Timepoint [8] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [9] 0 0
Phase 1: Mean change from baseline in QTcF interval
Timepoint [9] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [10] 0 0
Phase 2: Best overall response (BOR)
Timepoint [10] 0 0
Up to ~2 years
Secondary outcome [1] 0 0
Phase I: Best Overall Response (BOR)
Timepoint [1] 0 0
Up to ~2 years
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
Up to ~2 years
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Up to ~2 years
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
Up to ~2 years
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve (AUC) of brenetafusp
Timepoint [5] 0 0
At designated time points up to ~3 weeks
Secondary outcome [6] 0 0
Maximum plasma drug concentration (Cmax) of brenetafusp
Timepoint [6] 0 0
At designated time points up to ~3 weeks
Secondary outcome [7] 0 0
Time to reach maximum plasma concentration (Tmax) of brenetafusp
Timepoint [7] 0 0
At designated time points up to ~3 weeks
Secondary outcome [8] 0 0
Plasma elimination half-life (t½) of brenetafusp
Timepoint [8] 0 0
At designated time points up to ~3 weeks
Secondary outcome [9] 0 0
Incidence of anti-brenetafusp antibody formation
Timepoint [9] 0 0
Up to ~ 2 years
Secondary outcome [10] 0 0
Changes in lymphocyte counts over time
Timepoint [10] 0 0
Up to ~3 weeks
Secondary outcome [11] 0 0
Changes in serum cytokines over time
Timepoint [11] 0 0
Up to ~3 weeks
Secondary outcome [12] 0 0
Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria
Timepoint [12] 0 0
Up to ~2 years

Eligibility
Key inclusion criteria
1. ECOG PS 0 or 1
2. HLA-A*02:01 positive
3. PRAME positive tumor
4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
5. If applicable, must agree to use highly effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Symptomatic or untreated central nervous system metastasis
2. Recent bowel obstruction
3. Ongoing ascites or effusion requiring recent drainages
4. Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
5. Inadequate washout from prior anticancer therapy
6. Significant ongoing toxicity from prior anticancer treatment
7. Out-of-range laboratory values
8. Clinically significant lung, heart, or autoimmune disease
9. Ongoing requirement for immunosuppressive treatment
10. Prior solid organ or bone marrow transplant
11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
12. Significant secondary malignancy
13. Hypersensitivity to study drug or excipients
14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
15. Pregnant or lactating
16. Any other contraindication for applicable combination partner based on local prescribing information

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
25/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
727
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Melanoma Institute Australia (MIA) - The Poche Centre - Wollstonecraft
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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Iowa
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Massachusetts
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United States of America
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New Jersey
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New York
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United States of America
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Wisconsin
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Austria
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Salzburg
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Belgium
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Brussel
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Belgium
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Luik
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Porto Alegre
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Rio de Janeiro
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Ontario
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Gironde
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France
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France
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France
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Paris
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Germany
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Heidelberg
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Ireland
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Dublin
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Italy
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Roma
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Italy
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Napoli
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Korea, Republic of
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Seoul
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Netherlands
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CX
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Netherlands
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GZ
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ZA
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New Zealand
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Auckland
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Poland
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Skórzewo
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Poland
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Warszawa
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Basel
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Switzerland
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Lausanne
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Zürich
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United Kingdom
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City Of London
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Oxfordshire
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Scotland
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Liverpool
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London
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Manchester
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United Kingdom
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Surrey Quays

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

Ethics approval
Ethics application status

Summary
Brief summary
Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.
Trial website
https://clinicaltrials.gov/study/NCT04262466
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
Immunocore Medical Information
Address 0 0
Country 0 0
Phone 0 0
844-466-8661
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/NCT04262466