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NCT05006794 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

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

Active
Registry status
Phase 1
Development phase
145
Enrollment target
13
Study locations

NCT05006794: Active Phase 1 study of Solid Malignancies, sponsored by Gilead Sciences.

NCT05006794 is a Phase 1 study of Solid Malignancies that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 145 participants, above the 57-participant average among 3 other Solid Malignancies trials with a reported enrollment target (154% higher). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05006794, a Phase 1 study of Solid Malignancies, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
145 participants
Enrollment target
13
Study locations

Study Summary

This is a Phase I open-label, multi-center study of zamzetoclax (formerly GS-9716) tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.

Conditions Studied

Interventions

  • DRUG Docetaxel
  • DRUG zamzetoclax
  • DRUG sacituzumab govitecan-hziy

Study Locations (13)

Other

  • Rambam Health Care Campus - Haifa
  • Hadassah Medical Center- Ein Kerem - Jerusalem
  • Tel-Aviv Sourasky Medical Center - Tel Aviv

Colorado

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) - Aurora

Florida

  • Moffitt Cancer Center - Tampa

Michigan

  • START Midwest - Grand Rapids

New York

  • Montefiore Medial Center - Montefiore Medical Park - The Bronx

North Carolina

  • Novant Health Cancer Institute - Elizabeth (Breast Cancer) - Charlotte

Oklahoma

  • Stephenson Cancer Center - Oklahoma City

Oregon

  • Oregon Health Oregon Health & Sciences University-Knight Cancer Institute - Portland

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2021-09-15
Est. Completion 2029-03
Phase Phase 1
Gilead Sciences

504 total trials

What the registry record for NCT05006794 still lists

NCT05006794 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 57-participant average among 3 other Solid Malignancies trials with a reported enrollment target (154% higher).

The record links to 1 condition, with Solid Malignancies appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.

NCT05006794 lists 13 locations in 11 states (Other, Colorado, Florida).

Frequently Asked Questions

What is clinical trial NCT05006794 about?

NCT05006794 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies". This is a Phase I open-label, multi-center study of zamzetoclax (formerly GS-9716) tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose...

What is the current status of trial NCT05006794?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2021-09-15. Estimated completion is 2029-03.

What conditions does trial NCT05006794 study?

This clinical trial studies the following conditions: Solid Malignancies.

What interventions are being tested in trial NCT05006794?

The interventions under investigation include: Docetaxel (DRUG), zamzetoclax (DRUG), sacituzumab govitecan-hziy (DRUG).

Who is sponsoring clinical trial NCT05006794?

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

Where is trial NCT05006794 being conducted?

This trial has 13 study locations across Colorado, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05006794, the US trial registry maintained by the National Library of Medicine. NCT05006794 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.