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Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
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.
Study details:
The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-02-25
Primary completion: 2026-02-01
Study completion finish: 2026-08-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT04262466
Intervention or treatment
DRUG: Brenetafusp
DRUG: Brenetafusp and pembrolizumab
DRUG: Brenetafusp and chemotherapy
DRUG: Brenetafusp and monoclonal antibodies and chemotherapy
DRUG: Brenetafusp and tebentafusp
DRUG: Brenetafusp and bevacizumab
DRUG: Brenetafusp and kinase inhibitors
Conditions
- • Select Advanced Solid Tumors
Find a site
Closest Location:
Scientia Clinical Research
Research sites nearby
Select from list below to view details:
Scientia Clinical Research
Randwick, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Melanoma Institute Australia (MIA) - The Poche Centre
Wollstonecraft, New South Wales, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Brenetafusp Monotherapy
| DRUG: Brenetafusp
|
EXPERIMENTAL: Brenetafusp and Anti-PD(L)1 Agent
| DRUG: Brenetafusp and pembrolizumab
|
EXPERIMENTAL: Brenetafusp and Chemotherapy
| DRUG: Brenetafusp and chemotherapy
|
EXPERIMENTAL: Brenetafusp and Targeted Therapy
| DRUG: Brenetafusp and tebentafusp
|
EXPERIMENTAL: Brenetafusp and Multimodal Therapy
| DRUG: Brenetafusp and monoclonal antibodies and chemotherapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1: Incidence of dose-limiting toxicity (DLT)s | Not Specified | Up to ~28 days after each dose |
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE) | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations | Not Specified | Up to ~12 months |
Phase 1: Number of participants with abnormal laboratory test results (hematology) | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Number of participants with abnormal laboratory test results (chemistry) | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Number of participants with abnormal laboratory test results (coagulation) | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Number of participants with abnormal urinalysis | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Number of participants with abnormal vital signs | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 1: Mean change from baseline in QTcF interval | Not Specified | Up to 30 days after the last dose of study therapy |
Phase 2: Best overall response (BOR) | Not Specified | Up to ~2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Phase I: Best Overall Response (BOR) | Not Specified | Up to ~2 years |
Progression-free survival (PFS) | Not Specified | Up to ~2 years |
Duration of response (DOR) | Not Specified | Up to ~2 years |
Overall survival | Not Specified | Up to ~2 years |
Area under the plasma concentration-time curve (AUC) of brenetafusp | Not Specified | At designated time points up to ~3 weeks |
Maximum plasma drug concentration (Cmax) of brenetafusp | Not Specified | At designated time points up to ~3 weeks |
Time to reach maximum plasma concentration (Tmax) of brenetafusp | Not Specified | At designated time points up to ~3 weeks |
Plasma elimination half-life (t½) of brenetafusp | Not Specified | At designated time points up to ~3 weeks |
Incidence of anti-brenetafusp antibody formation | Not Specified | Up to ~ 2 years |
Changes in lymphocyte counts over time | Not Specified | Up to ~3 weeks |
Changes in serum cytokines over time | Not Specified | Up to ~3 weeks |
Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria | Not Specified | Up to ~2 years |
Frequently Asked Questions
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