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CAR T-cell Therapy

CFT1946 + Trametinib for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by C4 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 or 1
Subject must have received ≥1 prior line of SoC therapy for their unresectable locally advanced or metastatic disease with disease progression on or after last prior treatment
Must not have
Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers, including any herbal medications/supplements
Subject has presence of Grade ≥2 toxicity due to prior cancer therapy, excepting alopecia and hypothyroidism requiring thyroid replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 43 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the safety and effectiveness of CFT1946 as a cancer treatment, alone and with other drugs.

Who is the study for?
Adults with BRAF V600 mutant solid tumors who've had at least one prior treatment can join. They must be able to swallow pills, have good performance status and organ function, and agree to contraception rules. Excluded are those with certain other cancers, recent major surgery, CNS metastases unless stable, uncontrolled diabetes (for combination therapy), live vaccines recently, hepatitis B/C or HIV infections, recent serious cardiovascular events, eye disease risks (for combination therapy), lung conditions like pneumonitis or interstitial lung disease.
What is being tested?
The trial is testing CFT1946 alone (Arm A) and combined with trametinib (Arm B) in patients with specific types of cancer including melanoma and lung cancer. It aims to find the safest maximum dose for future phases of research by monitoring participants' reactions.
What are the potential side effects?
Potential side effects include typical drug reactions such as nausea and fatigue but may also involve more serious issues related to liver or kidney function due to the nature of these medications. Specific side effects for trametinib could include vision changes or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I've had at least one standard treatment for my advanced cancer and it has gotten worse after the last treatment.
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I am 18 years old or older.
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My cancer has a BRAF V600 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking strong CYP3A4/5 inhibitors or inducers, including herbal supplements.
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I have side effects from cancer treatment, but not hair loss or treatable thyroid issues.
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I have heart problems that are considered significant.
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I have not received a live vaccine in the last 28 days.
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I have no other cancers needing treatment in the last 3 years, except those treated with the intent to cure.
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I have a history of hepatitis B or an active hepatitis C infection.
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I have had uveitis before.
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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 43 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of Response (DOR)
Incidence of dose limiting toxicities (DLTs)
Secondary study objectives
Assess the pharmacodynamics by percent reduction from baseline of target protein
Disease control rate (DCR) at 3, 6, and 12 months
Duration of response (DOR)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2: Arm C1: CFT1946 + cetuximabExperimental Treatment2 Interventions
Approximately 40 subjects with CRC (post BRAF inhibitor)
Group II: Phase 2: Arm B1: CFT1946 + trametinibExperimental Treatment2 Interventions
Approximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
Group III: Phase 2: Arm A1: CFT1946Experimental Treatment1 Intervention
Approximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
Group IV: Phase 1: Arm C: CFT1946 + cetuximabExperimental Treatment2 Interventions
Approximately 30 subjects with CRC (post BRAF inhibitor)
Group V: Phase 1: Arm B: CFT1946 + trametinibExperimental Treatment2 Interventions
Approximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
Group VI: Phase 1: Arm A: CFT1946Experimental Treatment1 Intervention
Approximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1630
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
274 Total Patients Enrolled

Media Library

CFT1946 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05668585 — Phase 1 & 2
Melanoma Research Study Groups: Phase 1: Arm C: CFT1946 + cetuximab, Phase 2: Arm C1: CFT1946 + cetuximab, Phase 1: Arm A: CFT1946, Phase 1: Arm B: CFT1946 + trametinib, Phase 2: Arm A1: CFT1946, Phase 2: Arm B1: CFT1946 + trametinib
Melanoma Clinical Trial 2023: CFT1946 Highlights & Side Effects. Trial Name: NCT05668585 — Phase 1 & 2
CFT1946 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05668585 — Phase 1 & 2
~113 spots leftby Mar 2027
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