Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Key Inclusion Criteria:

Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
- NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
- HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
- Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
- Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
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 and renal function (CrCl ≥30mL/min)
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

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
Additional cohort specific exclusion criteria

Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

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Eligibility

Key Inclusion Criteria:

Key Exclusion Criteria:

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

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