Clinical Trials /

FS120 First in Human Study in Patients With Advanced Malignancies

NCT04648202

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: FS120 First in Human Study in Patients With Advanced Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: FS120-19101
  • NCT ID: NCT04648202

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
FS120FS120 Q4W

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FS120 Q4WExperimentalThe 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.
  • FS120

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
Time Frame:15 months
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:F-star Beta Limited

Trial Keywords

  • Immuno-oncology
  • bispecific antibody
  • dose escalation
  • cohort expansion
  • OX40
  • CD137
  • F-star

Last Updated

December 1, 2020