A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies

Summary

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.

Timeline

Start

2018-04-16

Primary completion

2024-06-21

Completion

2024-06-21

Outcome

Outcome not reported

Stopped (Business): “Business Decision”

Publications

• Yap TA, LoRusso PM, Wong DJ, Hu-Lieskovan S, Papadopoulos KP, Holz JB, Grabowska U, Gradinaru C, Leung KM, Marshall S, Reader CS, Russell R, Sainson RCA, Seal CJ, Shepherd CJ, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clin Cancer Res. 2023 Mar 1;29(5):888-898. doi: 10.1158/1078-0432.CCR-22-1449.

Drugs

Indications