drugset / Trial / 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

NCT05006794

Phase 1 Terminated 37 enrolled Gilead Sciences
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2021-09-15
Primary completion
2025-06-16
Completion
2025-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject zamzetoclax Small molecule Oral
Background Docetaxel Small molecule Intravenous
Background Sacituzumab Govitecan Monoclonal antibody Intravenous

Indications