FS118 First in Human Study in Patients With Advanced Malignancies After PD-1/PD-L1 Containing Therapy



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:April 16, 2018
End Date:May 16, 2020
Contact:Melinda Snyder
Email:FS118@f-star.com
Phone:617-233-4057

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A Phase 1, Open-Label, Dose-Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients With Advanced Malignancies That Have Progressed On or After Prior PD-1/PD-L1 Containing Therapy

This study will be conducted in adult patients diagnosed with advanced tumors to characterize
the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1,
multi-center, open label, multiple-dose, first in human study, designed to systematically
assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or
recommended Phase 2 dose (RP2D) for FS118 in patients with advanced tumors. Pharmacokinetics,
pharmacodynamics, immunogenicity, and response will also be assessed.


Inclusion Criteria:

- Age ≥18 years;

- Patients with histologically confirmed, locally advanced, unresectable, or metastatic
solid tumors or hematological malignancies that progressed while on or after
PD-1/PD-L1 containing therapy;

- Measurable disease;

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;

- Life expectancy estimated to be at least 3 months;

- Highly effective contraception

- Willing and able to provide written informed consent.

Exclusion Criteria:

- Prior treatment with more than 1 checkpoint inhibitor (combination); prior treatment
with a lymphocyte-activation gene 3 (LAG-3) inhibitor; prior treatment with multi
specific checkpoint inhibitor molecules;

- Patients with active or documented history of autoimmune disease;

- History of uncontrolled intercurrent illness:

- Known infections:

- Uncontrolled CNS metastases, primary CNS tumors, or solid tumors with CNS metastases
as only measurable disease;

- 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;

- Significant cardiac abnormalities;

- Significant laboratory abnormalities;

- Intolerance to the investigational product or its excipients, or any condition that
would significantly impair and/or prohibit the patient's participation in the study,
as per the Investigator's judgment.
We found this trial at
4
sites
San Antonio, Texas 78229
Principal Investigator: Kyri Papadopoulos, MD
Phone: 210-593-5242
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Houston, Texas 77030
Principal Investigator: Timothy A Yap, MD, PhD
Phone: 713-745-6274
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Houston, TX
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Los Angeles, California 90095
Principal Investigator: Deborah Wong, MD, PhD
Phone: 310-794-6913
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Los Angeles, CA
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Patricia LoRusso, DO
Phone: 203-737-5228
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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