A Phase Ia/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects With Solid Malignancies

Study Identifier:
GS-US-467-5643
CT.gov Identifier:
NCT05006794
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

To Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A: zamzetoclax Dose-Escalation
    • Read More
  • Drug: Experimental: Part A: zamzetoclax Dose-Expansion
  • Drug: Experimental: Part B (Cohort B1): Zamzetoclax + docetaxel
  • Drug: Drug: Docetaxel
  • Drug: Experimental: Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy
  • Drug: Drug: sacituzumab govitecan-hziy
  • Drug: Experimental: Part C (Cohort C1): zamzetoclax + docetaxel
  • Drug: Experimental: Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Measurable disease per RECIST version 1.1
    • Adequate hematology, renal and hepatic function
    • Left ventricular ejection fraction (LVEF) ≥ 50%
    • Patients with brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1)
    • Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception, per protocol.
    • Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agree to have a biopsy taken.
    • Part A Specific Inclusion Criteria: zamzetoclax as monotherapy
    • Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated.
    • Cohorts B1 and C1 Specific Inclusion Criteria:
    • Histologically or cytologically confirmed unresectable metastatic or locally advanced disease following treatment for metastatic disease including an immune checkpoint inhibitor and a platinum-containing chemotherapy
    • Patients with actionable genomic alterations must have also received treatment with at least 1 approved therapy appropriate to the genomic alteration unless unavailable or contraindicated
    • Cohorts B4 and C4 Specific Inclusion Criteria:
    • Histologically or cytologically confirmed disease based on the most recent analyzed biopsy metastatic disease that is refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens, one of which was a taxane (unless contraindicated).
    Exclusion criteria
    • Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol
    • Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapy within 2 weeks of the first dose of zamzetoclax (low dose corticosteroids permitted).
    • Women who are pregnant or lactating
    • Patients with active ≥ Grade 2 nausea or vomiting, and/or signs of intestinal obstruction
    • Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive
    • Known history of clinically significant cardiovascular disease or heart failure.
    • Known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory illness present within 6 months prior to C1D1
    • Known history of other clinically significant pulmonary disease or evidence of active pneumonitis
    • Uncontrolled pleural effusion, pericardial effusion, or ascites
    • History of clinically significant bleeding, intestinal obstruction, or gastrointestinal (GI) perforation within 6 months prior to C1D1
    • Infection requiring intravenous anti-infective use within 2 weeks prior to C1D1
    • Active or history of autoimmune disease or immune deficiency
    • History of uncured coexisting cancer, not including uncured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer.
    • Cohort A Specific Exclusion Criteria: zamzetoclax as monotherapy:
    • Known heart failure or elevated cardiac biomarkers
    • Cohorts B1 and C1 Specific Exclusion Criteria:
    • Known hypersensitivity to excipients in study treatments.
    • Cohorts B4 and C4 Specific Exclusion Criteria:
    • Prior treatment with sacituzumab govitecan-hziy or a topoisomerase 1 inhibitor or agents targeting Trop-2.
    • Note: Other protocol defined

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor