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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Zimberelimab; Drug: GS-9911

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
• Canada
  • Toronto, Canada, M5G
    • University Health Network, Princess Margaret Cancer Centre
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Smilow Cancer Hospital Phase 1 Unit
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics, LLC
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: GS-9911 Monotherapy Dose Escalation; Participants will receive escalating doses of GS-9911 monotherapy.	Drug: GS-9911; Tablets administered orally
Experimental: Part B: GS-9911 Monotherapy Dose Expansion; Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.	Drug: GS-9911; Tablets administered orally
Experimental: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody; Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).	Drug: Zimberelimab; Administered intravenously; Drug: GS-9911; Tablets administered orally
Experimental: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody; Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).	Drug: Zimberelimab; Administered intravenously; Drug: GS-9911; Tablets administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events	First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events	First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts	First dose date up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of GS-9911		Predose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: Cmax of GS-9911	Cmax is defined the maximum observed plasma drug concentration.	Predose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-9911	Tmax is defined as the time to maximum observed concentration.	Predose up to end of treatment (up to 105 weeks)
Area Under the Concentration-Time Curve (AUC) of GS-9911	AUC is defined as the area under the concentration versus time curve.	Predose up to end of treatment (up to 105 weeks)

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; zimberelimab
• Other Study ID Numbers: GS-US-521-6317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No