A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)

Brief Title

Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

Official Title

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment

Secondary Outcome

 Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment

Condition

Metastatic Solid Tumor

Intervention

Sacituzumab Govitecan-hziy

Study Arms / Comparison Groups

 Sacituzumab Govitecan-hziy

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 15, 2019

Completion Date

February 2025

Primary Completion Date

August 2023

Eligibility 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gilead Study Director, 1-833-445-3230 (GILEAD-0), [email protected]

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations

NCT ID

NCT03964727

Organization ID

IMMU-132-11

Responsible Party

Sponsor

Study Sponsor

Gilead Sciences

Study Sponsor

Gilead Study Director, Study Director, Gilead Sciences

Verification Date

May 2022