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NCT06082960 | RECRUITING | Solid Tumors

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Sponsor:

Gilead Sciences

Brief Summary:

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors

Condition or disease

Solid Tumors

Intervention/treatment

GS-9911

Zimberelimab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
Actual Study Start Date : 2023-10-09
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

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
  • * Parts A, C, and D
    • * Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
    • * Part B
      • * Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
      • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • * Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria
      • * Adequate organ functions
      • * Tissue requirement
        • * Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment
        • * Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible
        • * Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception
        Exclusion Criteria
        • * Positive serum pregnancy test or lactating female
        • * History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy
        • * Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (\< 4 weeks), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (\< 14 days), radiation therapy (\< 21 days), live vaccine (\< 28 days)
        • * Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation
        • * Diagnosis of immunodeficiency, or requires systemic corticosteroids (\> 10 mg of prednisone daily, or equivalent)
        • * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug
        • * History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis)
        • * Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll.
        • * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
        • * Symptomatic cardiovascular disease
        • * Active serious infection requiring ongoing treatment
        • * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV.
        • * Symptomatic ascites or pleural effusion
        • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

Location Details

NCT06082960

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, Connecticut

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

NEXT Oncology

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

RECRUITING

Canada,

University Health Network, Princess Margaret Cancer Centre

Toronto, Canada, M5g