Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05006794 | RECRUITING | Solid Malignancies

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

Gilead Sciences

Brief Summary:

This is a Phase I open-label, multi-center study of zamzetoclax (formerly GS-9716) tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.

Condition or disease

Solid Malignancies

Intervention/treatment

zamzetoclax

Docetaxel

sacituzumab govitecan-hziy

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 195 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1a/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
Actual Study Start Date : 2021-09-15
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • General Inclusion Criteria (all cohorts)
    • * 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).
        • Key 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 Inclusion/Exclusion criteria may apply.
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

Location Details

NCT05006794

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

COMPLETED

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, New York

Montefiore Medial Center - Montefiore Medical Park

Bronx, New York, United States, 10467

RECRUITING

United States, North Carolina

Novant Health Cancer Institute - Elizabeth (Breast Cancer)

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, Oklahola

Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104

COMPLETED

United States, Oregon

Oregon Health Oregon Health & Sciences University-Knight Cancer Institute

Portland, Oregon, United States, 97239

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

START San Antonio

San Antonio, Texas, United States, 78229

COMPLETED

United States, Utah

START Mountain Region

West Valley City, Utah, United States, 84119

RECRUITING

Israel,

Rambam Health Care Campus

Haifa, Israel, 31096

RECRUITING

Israel,

Idolate Medial Idol.

Jerusalem, Israel, 91120

RECRUITING

Israel,

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906