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 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

 Overall 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 squameous cell carcinoma (HNSCC), or endometrial cancer 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

December 2022

Primary Completion Date

December 2022

Eligibility Criteria

        Key Inclusion Criteria:

          -  Able to understand and give written informed consent.

          -  Individuals with the following histologically documented metastatic (M1, Stage IV) or
             locally advanced solid tumors. Tumor blocks (preferably, obtained within 12 months of
             study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of
             archived biopsy/surgical specimens are requested. these specimens should be submitted
             within 28 days before initiating Screening, after the individual provides written
             informed consent. A baseline biopsy is required if archival tissue is not available.
             Fine needle aspirations and bone biopsies are not suitable samples.

               -  Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma
                  (SCC)), that has progressed after prior platinum-based chemotherapy and
                  Programmed death-ligand 1 (PD-L1) or Programmed cell death protein 1 (PD-1)
                  directed therapy; recurrence/ relapse or lack of response within 6 months of
                  completion of chemotherapy for locally advanced disease, that line of therapy may
                  be counted for eligibility.

               -  Incurable, recurrent, or metastatic HNSCC that has progressed after prior
                  platinum based chemotherapy and PD-LI or PD-1 directed therapy

               -  Relapsed unresectable endometrial cancer that has progressed after prior platinum
                  based chemotherapy or is refractory to platinum based chemotherapy

          -  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 function

          -  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. Tumor
             lesions situated in a previously irradiated area may be utilized if they are
             considered measurable and progression has been demonstrated in such lesions.

        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

        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

United States

Location Countries

United States

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

June 2021