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

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

NCT ID: NCT06082960

Condition: Solid Tumors

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: GS-9911
Description: Tablets administered orally
Arm group label: Part A: GS-9911 Monotherapy Dose Escalation
Arm group label: Part B: GS-9911 Monotherapy Dose Expansion
Arm group label: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody
Arm group label: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody

Intervention type: Drug
Intervention name: Zimberelimab
Description: Administered intravenously
Arm group label: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody
Arm group label: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody

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

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Smilow Cancer Hospital Phase 1 Unit

Address:
City: New Haven
Zip: 06520
Country: United States

Status: Recruiting

Facility:
Name: SCRI Oncology Partners

Address:
City: Nashville
Zip: 37203
Country: United States

Status: Recruiting

Facility:
Name: NEXT Oncology

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Facility:
Name: South Texas Accelerated Research Therapeutics, LLC

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Facility:
Name: Peter MacCallum Cancer Centre

Address:
City: Melbourne
Zip: 3000
Country: Australia

Status: Recruiting

Facility:
Name: University Health Network, Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G
Country: Canada

Status: Recruiting

Start date: October 9, 2023

Completion date: November 2026

Lead sponsor:
Agency: Gilead Sciences
Agency class: Industry

Source: Gilead Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06082960
https://www.gileadclinicaltrials.com/study?nctid=NCT06082960