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Trial record 1 of 1 for:    FS120
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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

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE November 18, 2020
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE FS120 First in Human Study in Patients With Advanced Malignancies
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Metastatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: FS120
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: F-star Clinical Trials +44 1223 497400
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04648202
Other Study ID Numbers  ICMJE FS120-19101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F-star Therapeutics Limited
Study Sponsor  ICMJE F-star Therapeutics Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account F-star Therapeutics Limited
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP