Abexinostat + Pembrolizumab for Advanced Solid Tumor Malignancies

Recruiting in Palo Alto (17 mi)

Overseen byRahul Aggarwal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Rahul Aggarwal

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial studies the best dose and side effects of combining abexinostat and pembrolizumab in patients with certain types of cancer that have spread. Abexinostat may stop tumor growth by blocking certain enzymes, while pembrolizumab helps the immune system attack cancer cells. Pembrolizumab has been used effectively in treating various cancers, including melanoma and lung cancer. The goal is to find a more effective treatment for patients whose tumors have not responded to previous therapies.

Eligibility Criteria

Inclusion Criteria

Has provided signed informed consent before initiation of any study-specific procedures or treatment

Patient >= 18 years of age at the time of study enrollment

Agrees to use acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 6 months after the last treatment with study treatment

+7 more

Exclusion Criteria

Has a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within specified timeframe before study treatment

Has uncontrolled intercurrent illness

Has received external-beam radiation or another systemic anticancer therapy within specified timeframes before start of study treatment

+11 more

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Dose Escalation: (abexinostat, pembrolizumab)Experimental Treatment2 Interventions

Participants receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort B: Dose Expansion (abexinostat, pembrolizumab)Experimental Treatment2 Interventions

Participants with acquired resistance, defined as treatment duration on prior CPI for greater than 6 months with evidence of clinical benefit (tumor regression or disease stabilization) with subsequent disease progression will receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group III: Cohort A: Dose Expansion (abexinostat, pembrolizumab)Experimental Treatment2 Interventions

Participants with primary resistance to prior anti-PD-1/PD-L1 will receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.