A Phase 1/2, Open-Label, First-In-Human Study To Evaluate The Safety And Anti-Tumor Activity Of Fs118, A Lag-3/Pd-L1 Bispecific Antibody, In Patients With Advanced Malignancies
Posted Date: Oct 28, 2021
- Investigator: Christopher Lemmon
- Specialties: Cancer, Head and Neck Cancer, Oncology
- Type of Study: Drug
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). Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed. Efficacy will be determined by dose escalations and expansion cohort. Dosing of participants will occur intravenously (IV) weekly in 3-week treatment cycles until iCPD (i.e., immune confirmed progressive disease), unacceptable toxicity, or discontinuation.
Criteria:
Participants With Histologically Confirmed, Locally Advanced, Unresectable, Or Metastatic Solid Tumors That Progressed While On Or After Pd-1/Pd-L1 Containing Therapy. Participants Must Have Measurable Disease. Patients Must Have Ecog Performance Status =
Keywords:
Phase 1, Head And Neck, Cancer
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com