RecruitingPhase 1Phase 2NCT04826341

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors


Sponsor

National Cancer Institute (NCI)

Enrollment

120 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help. Objective: To find a safe combination of sacituzumab govitecan and berzosertib and to see if this will cause small cell lung cancer and PARP inhibitor resistant tumors to shrink. Eligibility: People ages 18 and older with a solid tumor, small cell lung cancer, or a homologous recombination-deficient cancer that is resistant to PARP inhibitors Design: Participants will be screened with: Standard clinical exams and tests EKG to test the heart Medical documentation to confirm cancer diagnosis Participants will get sacituzumab govitecan by vein on days 1 and 8 of each 21-day cycle. They will get berzosertib by vein on days 2 and 9. Treatment will continue as long as they can tolerate the drugs and their tumors are either stable or getting better. Before treatment and at least once per cycle, participants will have a physical exam and blood tests. Before treatment and every 2 or 3 cycles, they will have a CT scan. They will have a contrast agent injected into a vein for the scan. Participants will give blood and hair samples and tumor biopsies for research. Biopsies will be taken with a small needle under imaging guidance. After they stop treatment, participants will have a visit 1 month later. They will then be contacted by phone or email every 3 months for the rest of their lives.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing two drugs given together — sacituzumab govitecan (an antibody that delivers chemotherapy directly to cancer cells) and berzosertib (a drug that disrupts how cancer cells repair their DNA) — in people with small cell lung cancer, certain rare neuroendocrine cancers, or cancers that have stopped responding to PARP inhibitors. **You may be eligible if...** - You are 18 years or older - You have small cell lung cancer, extra-pulmonary small cell or neuroendocrine cancer, or a cancer with DNA repair defects that has stopped responding to PARP inhibitor drugs - You are in reasonably good health (able to care for yourself) - Your blood counts and organ function are within acceptable ranges - You have not had chemotherapy in the past 2 weeks or radiation in the past 24 hours **You may NOT be eligible if...** - You had major surgery in the past 2 weeks - You have had prior treatment with sacituzumab govitecan - Your organ function is significantly impaired - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBerzosertib

Berzosertib will be supplied as 20 mg/mL M6620 to be diluted with 5% dextrose in water solution before intravenous infusion.

DRUGSacituzumab Govitecan

Sacituzumab Govitecan will be administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04826341


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