Clinical trial · Interventional
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
NCT03964727CI-TRIAL-00109690TROPiCS-03active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | Sacituzumab Govitecan | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]
- 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.
- interventionNames
- Drug: Sacituzumab Govitecan-hziy
- type
- EXPERIMENTAL
- label
- Cohort 1 Group 2: NSCLC (Adenocarcinoma)
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDSantin AD, Corr BR, Spira A, Willmott L, Butrynski J, Tse KY, Patel J, Mekan S, Wu T, Lin KW, Kuo P, Dumbrava EE. Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2024 Oct 10;42(29):3421-3429. doi: 10.1200/JCO.23.02767. Epub 2024 Jul 31. PMID 39083724
- BACKGROUNDMichel L, Jimeno A, Sukari A, Beck JT, Chiu J, Ahern E, Hilton J, Even C, Zanetta S, Mekan S, Patel J, Wu T, Dumbrava EE. Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results from the Phase II TROPiCS-03 Basket Study. Clin Cancer Res. 2025 Mar 3;31(5):832-838. doi: 10.1158/1078-0432.CCR-24-2523. PMID 39665770
- BACKGROUNDDowlati A, Chiang AC, Cervantes A, Babu S, Hamilton E, Wong SF, Tazbirkova A, Sullivan IG, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar SN. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. J Thorac Oncol. 2025 Jun;20(6):799-808. doi: 10.1016/j.jtho.2024.12.028. Epub 2025 Jan 2. PMID 39755168