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Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors - Trial NCT06082960

Access comprehensive clinical trial information for NCT06082960 through Pure Global AI's free database. This Phase 1 trial is sponsored by Gilead Sciences and is currently Recruiting. The study focuses on Solid Tumors. Target enrollment is 120 participants.

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NCT06082960
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06082960
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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

Study Focus

Solid Tumors

GS-9911

Interventional

drug

Sponsor & Location

Gilead Sciences

San Antonio,San Antonio,Melbourne, Australia,United States of America

Timeline & Enrollment

Phase 1

Oct 09, 2023

Nov 01, 2026

120 participants

Primary Outcome

Percentage of Participants With Treatment-emergent Adverse Events,Percentage of Participants With Treatment-emergent Serious Adverse Events,Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts

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

ICD-10 Classifications

Malignant neoplasm: Connective and soft tissue, unspecified
Malignant neoplasm of other connective and soft tissue
Carcinoma in situ, unspecified
Malignant neoplasms
Malignant neoplasm: Parametrium

Data Source

ClinicalTrials.gov

NCT06082960

Non-Device Trial