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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 43 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 43 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 43 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
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 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Arm B1: CFT1946 + trametinibExperimental Treatment2 Interventions
Approximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
Group II: Phase 2: Arm A1: CFT1946Experimental Treatment1 Intervention
Approximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
Group III: 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 IV: 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
~1550
Find a Location
Who is running the clinical trial?
C4 Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
208 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong CYP3A4/5 inhibitors or inducers, including herbal supplements.I agree to follow the study's rules about using contraception and not donating sperm or blood.I have side effects from cancer treatment, but not hair loss or treatable thyroid issues.My heart, liver, kidneys, and bone marrow are functioning well.I have not had major surgery in the last 3 weeks.I can safely swallow pills.I have diabetes that is not well-controlled and I will be receiving CFT1946 + trametinib.I am fully active or can carry out light work.I am not pregnant, breastfeeding, and willing to follow the study's birth control requirements.I've had at least one standard treatment for my advanced cancer and it has gotten worse after the last treatment.I have heart problems that are considered significant.I have not received a live vaccine in the last 28 days.I have no history or current issues with eye vein blockages or related conditions.My brain cancer is stable, and I haven't needed more steroids for at least a week.I have no other cancers needing treatment in the last 3 years, except those treated with the intent to cure.I have a history of hepatitis B or an active hepatitis C infection.I am 18 years old or older.I have had uveitis before.You have HIV, unless there are specific exceptions.You have a disease that can be measured using a specific set of guidelines.My cancer has a BRAF V600 mutation.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I haven't received blood products or growth factors in the last week.I haven't had a stroke or blood clot in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Arm A: CFT1946
- Group 2: Phase 1: Arm B: CFT1946 + trametinib
- Group 3: Phase 2: Arm A1: CFT1946
- Group 4: Phase 2: Arm B1: CFT1946 + trametinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers are administering this experiment?
"There are 5 sites offering this clinical trial, such as the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Centre in New york City, Sarah Cannon and HCA Research Institute based out of Nashville, Tennessee, and MD Anderson Cancer Center located in Houston."
Answered by AI
Are there any available opportunities to join this research initiative?
"Affirmative. According to the information listed on clinicaltrials.gov, this research effort is recruiting volunteers for participation. The initial posting date was December 8th 2022 and the most recent update occurred on December 19th 2022; 122 subjects are expected to join at 5 different sites."
Answered by AI
How extensive is the participation in this medical experiment?
"That is accurate. According to clinicaltrials.gov, this research study which was initially published on December 8th 2022, is actively seeking participants. A total of 122 patients need to be recruited from 5 separate medical facilities."
Answered by AI
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