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: 223 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 squamous cell carcinoma (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 [Creatinine Clearance (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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 6 patient groups

Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]

Experimental group

Description:

Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression will receive sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Cohort 1 Group 2: NSCLC (Adenocarcinoma)

Experimental group

Description:

Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Cohort 1 Group 3: NSCLC (SCC)

Experimental group

Description:

Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)

Experimental group

Description:

Participants with HNSCC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Cohort 3: Endometrial Cancer (EC)

Experimental group

Description:

Participants with EC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Experimental group

Description:

Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Treatment:

Drug: Sacituzumab Govitecan-hziy