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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06082960
Other study ID # GS-US-521-6317
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 9, 2023
Est. completion date November 2026

Study information

Verified date May 2024
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230
Email GileadClinicalTrials@gilead.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
GS-9911
Tablets administered orally
Zimberelimab
Administered intravenously

Locations

Country Name City State
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Canada University Health Network, Princess Margaret Cancer Centre Toronto
United States SCRI Oncology Partners Nashville Tennessee
United States Smilow Cancer Hospital Phase 1 Unit New Haven Connecticut
United States NEXT Oncology San Antonio Texas
United States South Texas Accelerated Research Therapeutics, LLC San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment-emergent Adverse Events First dose date up to 90 days post last dose (up to 105 weeks)
Primary Percentage of Participants With Treatment-emergent Serious Adverse Events First dose date up to 90 days post last dose (up to 105 weeks)
Primary Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts First dose date up to 3 weeks
Secondary Plasma Concentration of GS-9911 Predose up to end of treatment (up to 105 weeks)
Secondary 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)
Secondary 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)
Secondary 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)
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