NCT04747470

Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors

A Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is planned to be conducted in 2 parts: Part 1: Dose Escalation and Part 2: Safety Run-In and Randomized Expansion. The primary objectives of Part 1 are 1) To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors. 2) To determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-3583 as monotherapy in participants with advanced solid tumors. The primary objectives of Part 2 is to assess the safety and tolerability and to determine the RP2D of GS-3583 in combination with zimberelimab (ZIM) and platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) (Cohort A) or in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) (Cohort B).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GS-3583	Administered as an intravenous (IV) infusion
DRUG	Zimberelimab	Administered as an IV infusion
DRUG	Cisplatin	Administered as an IV infusion
DRUG	Carboplatin	Administered as an IV infusion
DRUG	5-Fluorouracil	Administered as an IV infusion
DRUG	Docetaxel	Administered as an IV infusion

Timeline

• Start date: 2021-03-25
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2021-02-10
• Last updated: 2024-09-03
• Results posted: 2024-09-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study