M6620 + Irinotecan for Cancer

Recruiting at23 trial locations

Overseen by Liza C. Villaruz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Liza C. Villaruz

Principal Investigator

University of Pittsburgh Cancer Institute LAO

Eligibility Criteria

Adults with metastatic or inoperable solid tumors, including pancreatic, colorectal, and small cell lung cancer. Participants must have certain organ functions within normal limits and a life expectancy over 12 weeks. They should be willing to use contraception and undergo mandatory biopsies if in the expansion cohort.

Inclusion Criteria

You need to have a certain level of a type of white blood cell called neutrophils.

I have a known DNA repair issue or specific cancer types like pancreatic, colorectal, or small cell lung cancer.

Your white blood cell count is 3,000 or higher.

Exclusion Criteria

I am not taking strong medication that affects liver enzyme activity.

I don't have any severe illnesses that would stop me from following the study's requirements.

My HIV is not well-managed.

Treatment Details

Interventions

• Berzosertib (PARP Inhibitor)
• Irinotecan Hydrochloride (Topoisomerase I inhibitor)

Trial Overview The trial is testing M6620 (berzosertib) combined with irinotecan hydrochloride to determine safe dosages and side effects. It targets patients whose tumors may not respond to standard treatments or for whom no standard treatment exists.

Participant Groups

Group I: Treatment (irinotecan, M6620) Experimental Treatment 5 Interventions

Patients receive irinotecan hydrochloride IV over 90 minutes and M6620 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy and collection of blood samples throughout the study and undergo CT at screening, throughout the study, and during follow up.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School