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No longer recruiting (closed or complete)Last updated: 3 April 2025

TROPiCS-03: This phase II study is evaluating the effect of targeted therapy (Sacituzumab Govitecan-hziy) in people with advanced non-small cell lung cancer, head and neck squamous cell carcinoma, endometrial cancer or small cell lung cancerA Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

TROPiCS-03

Clinical summary

Summary

Eligible participants will receive sacituzumab govitecan-hziy (10mg/kg) intravenously on Days 1 and 8 of a 21-day cycle.

Conditions

This trial is treating people with non-small cell lung cancer, head and neck squamous cell carcinoma, endometrial cancer, or small cell lung cancer

Eligibility

Inclusion

  • 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

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Gilead Sciences, Inc.

Scientific Title

A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

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