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

NCT03655613 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

APL-501

Humanized IgG4 monoclonal antibody against programmed death receptor-1 (PD-1)

DRUG

APL-101

Oral specific c-Met inhibitor

BIOLOGICAL

Nivolumab

Fully human IgG4 monoclonal antibody against PD-1

Sponsors & Collaborators

  • Apollomics Inc. (formerly CBT Pharmaceuticals, Inc.)

    collaborator UNKNOWN

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Apollomics (Australia) Pty. Ltd.

    lead INDUSTRY

Principal Investigators

  • Scott Houston · Apollomics (Australia) Pty. Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2021-12-15
Completion
2021-12-15

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655613 on ClinicalTrials.gov