Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Able to understand and give written informed consent.

• Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. Tumor blocks (preferably, obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of archived biopsy/surgical specimens are requested. these specimens should be submitted within 28 days before initiating Screening, after the individual provides written informed consent. A baseline biopsy is required if archival tissue is not available. Fine needle aspirations and bone biopsies are not suitable samples.

• Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma (SCC)), that has progressed after prior platinum-based chemotherapy and Programmed death-ligand 1 (PD-L1) or Programmed cell death protein 1 (PD-1) directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility.

• Incurable, recurrent, or metastatic HNSCC that has progressed after prior platinum based chemotherapy and PD-LI or PD-1 directed therapy

• Relapsed unresectable endometrial cancer that has progressed after prior platinum based chemotherapy or is refractory to platinum based chemotherapy

• Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1

• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation

• Adequate hepatic function

• Individual must have at least a 3-month life expectancy

• Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Key Exclusion Criteria:

• Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1

• Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent

• Have previously received topoisomerase I inhibitors

• Have an active second malignancy

• Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability

Note: Other protocol defined Inclusion/Exclusion criteria may apply.