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

  • STATUS
    Recruiting
  • participants needed
    119
  • sponsor
    Apollomics (Australia) Pty. Ltd.
Updated on 20 June 2021
Investigator
Shelly Nigam, MS
Primary Contact
Royal Melbourne Hospital (4.2 mi away) Contact
+7 other location
monoclonal antibodies
systemic therapy
cytokines
carcinoma
metastasis
nivolumab
c-MET
sorafenib
angiogenesis inhibitor
metastatic renal cell carcinoma
metastatic hepatocellular carcinoma

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.

Description

For each potential subject, there is a 28-day screening and eligibility assessment period before enrollment; the first dose of study treatment will be administered on Day 1 of Cycle 1 (C1D1) (Safety population). Subjects will continue to receive their assigned treatment throughout the study until the occurrence of confirmed disease progression [progressive disease (PD)] by irRECIST, death, unacceptable treatment-related toxicity, or until the study is closed by the Sponsor. During the treatment period, study visits will occur on Day 1, Day 2, Day 8, Day 15, Day 22 of Cycle 1 and Day 1 and Day 15 of every subsequent cycle. Subjects who experience a response [Complete Response (CR), Partial Response (PR)] 2 cycles, PD 1 plus APL-101 combination will be continued until disease progression based on irRECIST. Subjects should receive a minimal of 2 cycles of PD-1 and APL-101 for adequate evaluation of response (Evaluable population). Discontinuation of PD-1 and APL-101 should occur upon determination of disease progression as determined by irRECIST, intolerable toxicity or when the risk/benefit ratio is no longer beneficial for the subjects as determined by the Principal Investigator, or upon subject withdrawal of consent. Upon permanent discontinuation of study treatment, there is a Treatment Termination visit and three monthly follow-up visits for a 90-day safety follow-up visit period. Subjects who drop out before they complete the first cycle of combination treatment for reasons other than toxicity will be replaced

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Kidney Cancer, Liver Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma, liver cell carcinoma
Treatment Nivolumab, CBT-501, CBT-101, APL-501, APL-101
Clinical Study IdentifierNCT03655613
SponsorApollomics (Australia) Pty. Ltd.
Last Modified on20 June 2021

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