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: Muhammad Riaz
- 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.
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 =1. Patients Must Have A Life Expectancy Estimated To Be At Least 3 Months. Participants Must Have Highly Effective Contraception. Patients For The Expansion Cohort Must Have Histologically And/Or Cytologically Confirmed Recurrent/Metastatic (R/M) Scchn That Is Not Amenable To Curative Therapy By Surgery Or Radiation, Only 1 Prior Anti-Pd-1 Or Anti-Pd-L1 Therapy And Documented Pd-L1 Scoring =1% By Combined Positive Score Or Tumor Proportion Score As Part Of Their Treatment, An Anti-Pd-1 Or Anti-Pd-L1 Treatment Regimen Must Be The Last Prior Therapy Before Study Enrollment, Following No More Than 2 Prior Systemic Regimens For R/M Scchn, Acquired Resistance To An Anti-Pd-1- Or Anti-Pd-L1-Containing Therapy, And Agree To Undergo A Pre-Treatment And On-Treatment Core Or Excisional Biopsy. No Participant That Is Deemed At High Risk Of Fatal Outcome In Case Of Covid-19. No Participants With A History Of Covid-19 And Those Who Have Not Provided A Negative Test For Sars Cov-2 Infection Within 28 Days Of The Planned First Dose Date With Fs118. No Prior Therapy. No Participants With Active Or Documented History Of Autoimmune Disease. No History Of Uncontrolled Intercurrent Illness. No Known Infections. No Uncontrolled Cns Metastases, Primary Cns Tumors, Or Solid Tumors With Cns Metastases As Only Measurable Disease. No Prior History Of Or Active Interstitial Lung Disease Or Pneumonitis, Encephalitis, Seizures, Severe Immune Related Adverse Events With Prior Pd-1/Pd-L1 Containing Treatments. No Significant Cardiac Abnormalities.
Phase 1, Head And Neck, Cancer
For More Information:
Uc Cancer Center