CFI-402411 + Pembrolizumab for Solid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a new drug, CFI-402411, both alone and with pembrolizumab (an immunotherapy drug), to assess its safety and effects on solid tumors unresponsive to other treatments. The trial consists of several parts, with some participants receiving CFI-402411 alone and others in combination with pembrolizumab. It seeks individuals with advanced solid tumors, such as certain lung or skin cancers, who have not succeeded with other treatments. Participants should have measurable cancer and have tried at least one other therapy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CFI-402411 is generally well-tolerated. Studies found it safe at doses up to 560 mg taken once daily. While some side effects may occur, they are usually not serious and can be managed with medical care.
When combined with pembrolizumab, CFI-402411 also demonstrated a manageable level of side effects. Pembrolizumab, already approved by the FDA for certain types of cancer, has a well-established safety profile.
Overall, early results suggest that both CFI-402411 alone and in combination with pembrolizumab are tolerated by patients. However, as with any drug, individual experiences may vary, so discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CFI-402411 because it targets solid tumors in a new way. Unlike traditional treatments that focus on directly attacking cancer cells, CFI-402411 works by enhancing the immune system’s ability to fight cancer. This is achieved by inhibiting a specific protein that usually dampens immune responses. Additionally, when combined with pembrolizumab, a well-known immunotherapy, there's potential for a powerful synergistic effect that could improve treatment outcomes. These unique features offer hope for more effective options for patients with solid cancers.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that CFI-402411, one of the treatments in this trial, delivers promising results in controlling disease in patients with advanced solid tumors when used alone. In one study, 18% to 29% of patients experienced stable disease or partial improvement after three months of treatment. CFI-402411 blocks a protein called HPK1, which can help the body's immune system fight tumors.
In this trial, some participants will receive CFI-402411 combined with pembrolizumab, another treatment that aids the immune system in attacking cancer cells. Early results suggest that this combination may lead to better outcomes, with more tumor shrinkage in some patients, indicating a stronger immune response. Both treatments are generally well-tolerated, with manageable side effects.12346Who Is on the Research Team?
Omid Hamid, Dr
Principal Investigator
The Angeles Clinic, Los Angeles
Are You a Good Fit for This Trial?
Adults over 18 with advanced solid tumors that have worsened after at least one but no more than three systemic therapies. Eligible cancers include NSCLC, SCLC, urothelial, renal cell carcinoma, triple negative breast cancer, endometrial cancer regardless of MSI status, cervical cancer, gastroesophageal cancer, hepatocellular cancer or any tumor known to be MSI-H. Patients must have measurable disease and be in good physical condition (ECOG 0-1). They should not respond to standard treatments or tolerate them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CFI-402411 as a single agent or in combination with pembrolizumab to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CFI-402411
- Pembrolizumab
Trial Overview
The trial is testing CFI-402411's safety and effectiveness alone and combined with pembrolizumab for patients with advanced solid tumors who've had previous treatment failures. The study will assess how well these drugs work together and what side effects they may cause.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Dose expansion arm with the recommended phase 2 dose of CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
Dose escalation arm with CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
Dose expansion arm with CFI-402411 at its recommended phase 2 dose.
Dose escalation biomarker arm with CFI-402411. CFI-402411 is administered orally once daily.
Dose escalation arm with CFI-402411. CFI-402411 is administered orally once daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Treadwell Therapeutics, Inc
Lead Sponsor
TIO Discovery Engine
Collaborator
Citations
Safety and Efficacy Study of CFI-402411 in Subjects With ...
This study will be a first-in-human study evaluating the safety and tolerability of CFI-402411 in subjects with advanced solid malignancies, when CFI-402411 is ...
741 TWT-101: a first-in-clinic study of CFI-402411, ...
Disease control rates (CR, PR, or SD ≥ 6 weeks from baseline) at 3 months were 18% (A) and 29% (B). Two HNSCC pts achieved a PR (A: 400mg) and ...
Safety and Efficacy Study of CFI-402411 in Subjects With ...
The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its ...
Safety and Efficacy Study of CFI-402411 in Subjects With ...
CFI-402411 demonstrated a clinically manageable safety profile at doses up to 560 mg QD with exposures increasing proportionately with dose.
750 TWT-101: a first-in-clinic, phase 1/2 study of CFI- ...
Conclusions CFI-402411 is a well-tolerated, potent inhibitor of HPK1 with a manageable AE profile and initial evidence of activity. RP2D and ...
Clinical Trial: NCT04521413 - Breast Carcinoma
This study will be a first-in-human study evaluating the safety and tolerability of CFI-402411 in subjects with advanced solid malignancies, ...
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