CFT1946 + Trametinib for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CFT1946 to assess its safety and tolerability in people with certain solid tumors. Researchers aim to determine the best dose of CFT1946 alone and in combination with other drugs like trametinib or cetuximab. Suitable candidates for this trial have solid tumors with a specific BRAF V600 mutation and have previously tried treatments, including a BRAF inhibitor. The trial seeks to assist those whose cancer has not responded to standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking strong CYP3A4/5 inhibitors and inducers, including herbal medications. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found CFT1946 to be safe and generally well-tolerated by patients, with most experiencing no serious side effects. Some research suggests that combining CFT1946 with trametinib might enhance its effectiveness, though this combination can sometimes cause skin-related side effects. Overall, evidence so far suggests that CFT1946 is safe for humans, but further research is needed for confirmation.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about CFT1946 because it targets the V600 mutation seen in various solid tumors, offering a potentially more precise treatment approach. Unlike standard treatments like BRAF inhibitors, CFT1946 is designed to degrade mutant proteins that drive cancer growth, potentially overcoming resistance to existing therapies. When combined with trametinib, which inhibits a different part of the cancer cell growth pathway, CFT1946 might offer a more comprehensive attack on cancer cells, increasing effectiveness and reducing chances of recurrence. This combination could provide new hope for patients whose cancers have stopped responding to conventional treatments.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research has shown that CFT1946 has potential in early studies for treating certain tumors with a specific genetic change called BRAF V600. It generally tolerated well and could break down the BRAF V600E mutation, which often promotes cancer growth. Early evidence suggests that CFT1946 can shrink tumors, indicating possible effectiveness.
In this trial, some participants will receive CFT1946 alone, while others will receive a combination of CFT1946 and trametinib, a drug targeting a related cancer pathway. This combination is being tested to determine if it works better together than separately. The goal is to find a treatment that is both safe and effective at reducing tumors in patients with these specific genetic changes.12346Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CFT1946 as monotherapy or in combination with trametinib or cetuximab to determine the maximum tolerated dose and recommended Phase 2 dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Pharmacokinetics Assessment
Plasma concentration of CFT1946 is measured to characterize pharmacokinetics parameters
What Are the Treatments Tested in This Trial?
Interventions
- CFT1946
- Trametinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
C4 Therapeutics, Inc.
Lead Sponsor