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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. Identifier: NCT04648202
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : March 10, 2021
Information provided by (Responsible Party):
F-star Therapeutics Limited

Brief Summary:
This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS120. 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 FS120 in participants with advanced tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Drug: FS120 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: FS120
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years.
  • Participants with histologically confirmed, locally advanced, unresectable, or metastatic solid tumours that have failed up to 2 prior regimens for metastatic disease and standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.
  • For participants who have failed 1 prior immune-checkpoint blockade (ICB)-containing regimen, prior biomarker status must be documented; the minimum treatment duration was 12 weeks; and disease progression is documented for participants in the accelerated titration and confirmed for participants in later cohorts.
  • Measurable disease.
  • Eastern Cooperative Oncology Group Performance Status ≤1.
  • The participant agrees to undergo a pretreatment and on-treatment biopsy of the tumor.
  • Highly effective contraception.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Participants with clinically relevant COVID-19 disease risk will be excluded from enrolment during the COVID-19 pandemic.
  • Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination); prior therapy with more than 1 line of treatment with immune-checkpoint inhibitors (including ICB combination therapy).
  • Participants with active autoimmune disease.
  • History of uncontrolled intercurrent illness.
  • Significant laboratory abnormalities.
  • Participants with haematological malignancies; participants with treatment-refractory chronic bone marrow insufficiency; participants unresponsive and/or refractory to transfusions and supportive care for disease-related or treatment-related haematological toxicity(ies).
  • Participants with prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
  • Known infections.
  • Uncontrolled central nervous system (CNS) metastases, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.
  • Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome (CRS); systemic inflammatory response syndrome (SIRS).
  • Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade >1 NCI CTCAE Version 5.0 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgment.
  • Vaccination with a live vaccine within 30 days before first dose of study drug.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04648202

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Contact: F-star Clinical Trials +44 1223 497400

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United States, Connecticut
Yale University Recruiting
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         
Sponsors and Collaborators
F-star Therapeutics Limited
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Responsible Party: F-star Therapeutics Limited Identifier: NCT04648202    
Other Study ID Numbers: FS120-19101
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by F-star Therapeutics Limited:
bispecific antibody
dose escalation
cohort expansion
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes