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NCT06167317 · ClinicalTrials.gov registry record · Phase 1

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by Gilead Sciences.

Recruiting
Registry status
Phase 1
Development phase
254
Enrollment target
7
Study locations

NCT06167317 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 254 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (29% higher). The trial reports 7 study locations across 3 states.

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The verdict

NCT06167317, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Gilead Sciences.

RECRUITING
Registry status
Phase 1
Development phase
254 participants
Enrollment target
7
Study locations

Study Summary

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: * To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG Sacituzumab Govitecan
  • DRUG GS-0201

Study Locations (7)

Texas

  • NEXT Austin - Austin
  • The University of Texas MD Anderson Cancer Center - Houston
  • NEXT Dallas - Irving

Other

  • Rambam Health Care Campus - Haifa
  • Tel Aviv Sourasky Medical Center - Tel Aviv
  • Chaim Sheba Medical Center - Tel Litwinsky

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2024-01-09
Est. Completion 2028-09
Phase Phase 1

Sponsor

Gilead Sciences

504 total trials

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What the Registry Record Tells You About NCT06167317

The ClinicalTrials.gov registry entry for NCT06167317 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (29% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab Govitecan is the first listed.

NCT06167317 reports 7 study locations spanning 3 distinct geographic areas - top geographies include Texas, Other, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06167317 about?

NCT06167317 is a clinical study titled "Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors". The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: * To assess the safety and tolerability of...

What is the current status of trial NCT06167317?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 254 participants. The study started on 2024-01-09. Estimated completion is 2028-09.

What conditions does trial NCT06167317 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT06167317?

The interventions under investigation include: Sacituzumab Govitecan (DRUG), GS-0201 (DRUG).

Who is sponsoring clinical trial NCT06167317?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06167317 being conducted?

This trial has 7 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.