Study on Sacituzumab Govitecan and Berzosertib for Small Cell Lung Cancer and Other Resistant Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04826341

Provider View

This clinical trial is testing a new combination of drugs, sacituzumab govitecan and berzosertib, to see if they can safely and effectively shrink tumors in patients with small cell lung cancer and other cancers that are resistant to current treatments.

Patient Parameters

Program Overview

This study aims to find a safe and effective combination of two drugs, sacituzumab govitecan and berzosertib, to treat small cell lung cancer and other cancers that have not responded to existing treatments. The trial is open to adults aged 18 and older with specific types of cancer, including those resistant to PARP inhibitors.

Description

This clinical trial is exploring a new treatment for aggressive cancers like small cell lung cancer and tumors resistant to PARP inhibitors. These cancers are tough to treat with current methods, so researchers are testing a combination of two drugs: sacituzumab govitecan and berzosertib. Sacituzumab govitecan is a drug that targets cancer cells directly, while berzosertib is being studied for its ability to help overcome resistance to other treatments.

The study is divided into two phases. Phase I will determine the safest dose of the drug combination, while Phase II will assess how well the treatment works in shrinking tumors. Participants will receive the drugs in cycles, with sacituzumab govitecan given on days 1 and 8, and berzosertib on days 2 and 9 of each 21-day cycle. Treatment will continue as long as it is tolerated and effective.

Participants will undergo regular health checks, including physical exams, blood tests, and CT scans to monitor their response to the treatment. They will also provide blood, hair, and tumor samples for research purposes. After completing the treatment, participants will have a follow-up visit and will be contacted regularly to check on their health.

The study is open to adults with specific types of cancer, including small cell lung cancer and cancers with certain genetic mutations that make them resistant to PARP inhibitors. Participants must meet specific health criteria and agree to use effective birth control during the study and for a period afterward.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Have adequate organ and bone marrow function, as shown by specific blood tests.
  • Have stable brain metastases, if present, and not require steroids for treatment.
  • Agree to use effective contraception during the study and for 6 months after.
  • Be able to understand and sign a consent form.

Phase I:

  • Have advanced solid tumors that have progressed after at least one chemotherapy treatment.

Phase II HRD cohort:

  • Have a cancer with specific genetic mutations related to DNA repair.
  • Have measurable disease and be willing to undergo biopsies.
  • Have shown disease progression while on PARP inhibitors or within 6 months of stopping them.

Phase II SCLC and EP-SCNC:

  • Have recurrent small cell lung cancer or extra-pulmonary small cell neuroendocrine cancer after prior platinum-based therapy.
  • Have measurable disease and be willing to undergo biopsies.

Exclusion Criteria

  • Currently receiving other investigational drugs or cancer treatments.
  • Have a history of severe allergic reactions to similar drugs.
  • Have symptomatic brain metastases.
  • Require treatment with certain medications that interact with the study drugs.
  • Have uncontrolled illnesses or psychiatric conditions that could interfere with the study.
  • Be pregnant or breastfeeding.
  • Have blood disorders or acute myeloid leukemia.
  • Have untreated or uncontrolled HIV, hepatitis B, or hepatitis C infections.

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