NCT05006794

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 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects With Solid Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Solid Malignancies

Interventions

Type	Name	Description
DRUG	zamzetoclax	Tablet(s) administered orally
DRUG	Docetaxel	Administered intravenously
DRUG	sacituzumab govitecan-hziy	Administered intravenously

Timeline

• Start date: 2021-09-15
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2021-08-16
• Last updated: 2026-01-07

Locations

13 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study