Clinical Trials /

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

NCT03440437

Description:

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.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: FS118 First in Human Study in Patients With Advanced Malignancies After PD-1/PD-L1 Containing Therapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: FS118-17101
  • NCT ID: NCT03440437

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
FS118FS118 weekly

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FS118 weeklyExperimentalThe initial cohorts will enroll sequentially as single-patient cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design.
  • FS118

Eligibility Criteria

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

Primary Outcome Measures

Measure:Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time Frame:12 months
Safety Issue:
Description:Incidence, severity and duration of treatment emergent adverse events will be assessed by CTCAEv4.03

Secondary Outcome Measures

Measure:Disease Response as assessed by RECIST 1.1 or the Lugano classification, as applicable, and iRECIST
Time Frame:7 months
Safety Issue:
Description:Assessed by RECIST 1.1 or the Lugano classification, as applicable, and iRECIST
Measure:Incidence of FS118 immunogenicity
Time Frame:7 months
Safety Issue:
Description:Incidence of FS118 immunogenicity will include ADA detection and analysis (incidence measured in titre)

Details

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

Trial Keywords

  • FS118
  • Immuno-oncology
  • bispecific antibody
  • check-point inhibitor
  • dose escalation
  • cohort expansion
  • PK
  • PD
  • biomarker

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