Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (TROPiCS-03)

Gilead Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Solid Tumor

Treatments: Drug: Sacituzumab Govitecan-hziy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03964727

2019-000579-18 (EudraCT Number)

IMMU-132-11

2024-513611-28 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Sacituzumab Govitecan-hziy

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.

Treatment:

Drug: Sacituzumab Govitecan-hziy