A Phase 1/2 interventional study of APL-501 and APL-101 in Hepatocellular Carcinoma and Renal Cell Carcinoma, sponsored by Apollomics (Australia) Pty. Ltd.. Terminated at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Apollomics (Australia) Pty. Ltd. · Phase 1/2, Interventional, and Treatment
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.
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
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Apollomics (Australia) Pty. Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Biological: APL-501 · Drug: APL-101
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
Drug: APL-101 · Biological: Nivolumab
Humanized IgG4 monoclonal antibody against programmed death receptor-1 (PD-1)
Also known as: genolimzumab, GB226, CBT-501
Oral specific c-Met inhibitor
Also known as: bozitinib, vebreltinib, CBT-501
Fully human IgG4 monoclonal antibody against PD-1
Also known as: Opdivo
Dose Limiting Toxicities (Phase 1)
Dose limiting toxicities (DLTs)
Time frame: Cycle 1 (up to 35 days)
Adverse events
Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0. including immune related adverse events (irAEs)
Time frame: First dose up to 90 days post last dose (up to approximately 2 years)
Drug discontinuation due to adverse events
Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0. including immune related adverse events (irAEs)
Time frame: First dose up to 90 days post last dose (up to approximately 2 years)
Overall Response Rate
Tumor response will be assessed by immune related Response Evaluation Criteria in Solid Tumors (irRECIST)
Time frame: Duration of study, performed at baseline, then every 8 weeks until objective disease progression (up to approximately 2 years)
Time to Response
Time to response is the time from first dose to date of first response (Partial response or Complete response)
Time frame: Duration of study, first dose to first response (up to approximately 2 years)
Progression Free Survival
Progression free survival will be collected on all enrolled subjects, defined as the time from first dose to death from any cause or first observed disease progression
Time frame: Duration of study, performed at baseline, then every 8 weeks until objective disease progression at 6, 12, 18 and 24 months (up to approximately 2 years)
Overall Survival
Overall survival will be estimated using the Kaplan-Meier method with the follow-up starting at the initiation of therapy until date of death
Time frame: Duration of study, performed every 8 weeks from enrollment to death from any cause at 6, 12, 18, 24 months (up to approximately 2 years)
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Apollomics (Australia) Pty. Ltd.