FS120 First in Human Study in Patients With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04648202|
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : March 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Metastatic Cancer||Drug: FS120||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS120, an OX40/CD137 Bispecific Antibody, in Subjects With Advanced Malignancies|
|Actual Study Start Date :||November 18, 2020|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: FS120 Q4W
The initial cohorts will enroll sequentially as single-participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design.
Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
- Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs) [ Time Frame: 15 months ]Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
- Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) by evaluation of DLTs [ Time Frame: 28 days ]Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648202
|Contact: F-star Clinical Trials||+44 1223 email@example.com|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|Contact: Patricia LoRusso, DO|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Timothy Yap, MD, PhD|
|South Texas Accelerated Research Therapeutics (START)||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Kyriakos Papadopoulos, MD|