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

• Status: Recruiting
• Trial end date: 2028-05-01

Summary

The primary objective of Part A of this study is to define the maximum tolerated dose (MTD) or maximum administered dose of GS-9716 as monotherapy in advanced solid malignancies and to characterize the safety, and tolerability of GS-9716 monotherapy.

The primary objectives of Parts B and C of this study are: To characterize the safety, tolerability, and to define MTD and/or recommended Phase 2 dose (RP2D) of GS-9716 in combination with either docetaxel or sacituzumab govitecan-hziy in adults with metastatic non-squamous non-small cell lung cancer (NSCLC) following treatment for metastatic disease, including an immune checkpoint inhibitor and a single line of platinum containing chemotherapy (for Cohorts B1, B2, C1, and C2) and in adults with metastatic triple-negative breast cancer (TNBC) following a single line of therapy for metastatic disease (for Cohorts B3, B4, C3, and C4); To characterize the safety, tolerability, and to define MTD and/or the RP2D of GS-9716 in combination with gemcitabine and docetaxel in metastatic soft tissue sarcomas (mSTS) with nonspecific histologies previously untreated for metastatic disease (for Cohorts B5 and C5).

• Phase: Phase 1

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Docetaxel; Gemcitabine