Clinical Trials /

FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

NCT02325739

Description:

Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Safety and Efficacy of <span class="go-doc-concept go-doc-intervention">FGF401</span> in Patients With Solid Malignancies

Title

  • Brief Title: Safety and Efficacy of FGF401 in Patients With Solid Malignancies
  • Official Title: A Phase I/II, Multicenter, Open-label Study of FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression
  • Clinical Trial IDs

    NCT ID: NCT02325739

    ORG ID: CFGF401X2101

    Trial Conditions

    Solid Malignancies

    Trial Interventions

    Drug Synonyms Arms
    FGF401 Arm A, Arm B, Arm C

    Trial Purpose

    Estimate the maximum tolerated dose and/or recommended phase two dose and efficacy of FGF401
    on patients with solid malignancies

    Detailed Description

    Estimate the maximum tolerated dose and/or recommended phase two dose by detecting the Dose
    Limiting Toxicity and efficacy of FGF401 based on RECIST 1.1 on patients with solid
    malignancies

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental Approximately 40 patients enrolled FGF401
    Arm B Experimental Approximately 40 patients enrolled FGF401
    Arm C Experimental Approximately 20 patients enrolled FGF401

    Eligibility Criteria

    Inclusion Criteria:

    1. ECOG Performance Status 1

    2. Presence of at least one measurable lesion according to RECIST v1.1.

    3. Patients who have progressed despite standard therapy or are intolerant of standard
    therapy, or for whom no standard therapy exists.

    Exclusion Criteria:

    1. Previous treatment with a selective FGF19-FGFR4 targeted therapy and/or pan-FGFR
    inhibitor.

    2. Symptomatic CNS metastases which are neurologically unstable or requiring increasing
    doses of steroids to control their CNS disease.

    3. Patient having out of range laboratory values defined as:

    - Hematology Hemoglobin 9 g/dL (SI Units: 90 g/L) Platelet count < 75000/mm3
    Absolute neutrophil count (ANC) < 1500/mm3

    - Chemistry Total bilirubin 2 mg/dL AST and/or ALT > 3 x ULN Serum creatinine >
    1.5 x ULN and/or creatinine clearance 45 mL/min

    - Coagulation: PT 4 seconds or INR 1.7

    4. Pregnant or nursing (lactating) women.

    5. Patients receiving treatment with long acting proton pump inhibitors that cannot be
    discontinued 3 days prior to the start of study treatment and during the course of
    the study.

    Other protocol-defined Inclusion/Exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incidence rate of Dose-limiting Toxicity (DLT)

    Time to progression (TTP)

    Overall response rate (ORR)

    Secondary Outcome Measures

    Number of adverse events (AEs)/serious adverse events (SAEs)

    Best Overall Response (BOR)- phase I and phase II

    Overall Response Rate (ORR)- phase I and phase II Arm A and Arm B

    Disease Control Rate (DCR)- phase I and phase II

    Time to Progression (TTP)- phase I

    Overall Survival (OS)- phase I and phase II

    Progression-free Survival (PFS)- phase II Arm C

    Plasma concentration of FGF401 and Cmax, Cmin, AUCinf, AUClast, AUCtau and T1/2

    Trial Keywords

    FGF401, FGFR4, FGF19, solid malignancies