APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC

Sponsor
Apollomics (Australia) Pty. Ltd.
Study ID
NCT03655613
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APL-501 — BIOLOGICAL
    Humanized IgG4 monoclonal antibody against programmed death receptor-1 (PD-1)
  • APL-101 — DRUG
    Oral specific c-Met inhibitor
  • Nivolumab — BIOLOGICAL
    Fully human IgG4 monoclonal antibody against PD-1

Study Details

Study Design and Investigational Plan: This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor (APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive the combination APL-501 plus APL-101 while RCC subjects will receive the combination nivolumab plus APL-101. In Phase 1, mandatory archival or fresh tumor biopsies will be collected. In Phase 2, a mandatory fresh tumor biopsy will be required for study entry and another fresh biopsy will be collected between Cycles 2 and 4. The frequency of administration of PD-1 inhibitors will be every 2 weeks starting in Cycle 1 on Day 8 and Day 22 of a 35-day cycle with all subsequent cycles on Day 1 and Day 15 of 28-day cycles. APL-101 will be administered orally every 12 hours continuously on an empty stomach.

Key Dates

Start date
Sep 5, 2018
Status verified
May 2022
Primary completion
Dec 15, 2021
Completion
Dec 15, 2021

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Hepatocellular Carcinoma
    PD-1 inhibitor (APL-501) 3 mg/kg intravenously every 2 weeks + c-Met inhibitor (APL-101) 150 mg or 200 mg administered twice daily continuously until documented disease progression, discontinuation due to toxicity withdrawal of consent or the study ends
  • Experimental: Arm B: Renal Cell Carcinoma
    PD-1 inhibitor (nivolumab) 3 mg/kg or 240 mg intravenously every 2 weeks + c-Met inhibitor (APL-101) 300 mg or 400 mg administered twice daily continuously until documented disease progression, discontinuation due to toxicity withdrawal of consent or the study ends

Primary Outcome Measure

Dose Limiting Toxicities (Phase 1) [ Time Frame: Cycle 1 (up to 35 days) ]

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