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NCT06082960Recruiting

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
Gilead SciencesPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Solid Tumors
Drug/Device/Intervention
GS-9911
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Gilead Sciences
Location
San Antonio,San Antonio,Melbourne, Australia,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 09, 2023
End date
Nov 01, 2026
Enrollment
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, unspecifiedMalignant neoplasm of other connective and soft tissueCarcinoma in situ, unspecifiedMalignant neoplasmsMalignant neoplasm: Parametrium
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06082960
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.