A Phase 1 interventional study of ADI PEG20 and Pembrolizumab in Advanced Solid Cancers, sponsored by Polaris Group. Terminated at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Polaris Group · Phase 1, Interventional, and Treatment
This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and tolerability of drug combination
This is an open-label, phase 1b trial of ADI-PEG 20 in combination with pembrolizumab in subjects with advanced cancers. Dose escalation will occur using a 3 + 3 + 3 design.
The first subject in a dose escalation cohort must have had treatment with ADI-PEG 20 + pembrolizumab with a week of follow up) before the next 2 subjects are enrolled. Thus subjects 2 and 3 may be enrolled on day 8 if there is no dose limiting toxicity (DLT) in subject 1. No additional delay is required between treating subjects 4 to 6 or 7 to 9 in an expanded cohort. Before proceeding to the next cohort dose level, the first 3 eligible subjects in each cohort will have received at least 21 days of treatment (i.e. at least 2 of the expected 3 doses of ADI-PEG 20 + one dose of pembrolizumab).
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This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks.
Drug: ADI PEG20 · Drug: Pembrolizumab
ADI is a recombinant protein cloned from M. hominis and produced in E. coli, and conjugated with PEG of 20,000 mw. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.
Also known as: Keytruda®
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with Pembrolizumab in Advanced Solid Cancers
Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding
Time frame: Up to 36 months
Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
Progression Free Survival determined by RECIST 1.1
Time frame: Assessments ever 9 weeks for 12 months
Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
Response Rate determined by RECIST 1.1
Time frame: Assessments ever 9 weeks for 12 months
Overall Survival
Follow-Up by Phone or Clinic Visit
Time frame: 12 months after end of treatment
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Polaris Group