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

NCT06082960 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: GS-US-521-6317
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 6

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Plasma Concentration of GS-9911

  Predose up to end of treatment (up to 105 weeks)

• Pharmacokinetic (PK) Parameter: Cmax of GS-9911

  Predose up to end of treatment (up to 105 weeks)

• PK Parameter: Tmax of GS-9911

  Predose up to end of treatment (up to 105 weeks)

• Area Under the Concentration-Time Curve (AUC) of GS-9911

  Predose up to end of treatment (up to 105 weeks)

Study Arms (4)

Part A: GS-9911 Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of GS-9911 monotherapy.

Drug: GS-9911

Part B: GS-9911 Monotherapy Dose Expansion

EXPERIMENTAL

Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.

Drug: GS-9911

Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody

EXPERIMENTAL

Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Drug: GS-9911; Drug: Zimberelimab

Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody

EXPERIMENTAL

Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Drug: GS-9911; Drug: Zimberelimab

Interventions

GS-9911 DRUG

Tablets administered orally

Part A: GS-9911 Monotherapy Dose Escalation; Part B: GS-9911 Monotherapy Dose Expansion; Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody; Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody

Zimberelimab DRUG

Administered intravenously

Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody; Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (6)

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, 06520, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

University Health Network, Princess Margaret Cancer Centre

Toronto, M5G, Canada

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

zimberelimab

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (4); CA (1)