NCT03254732

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Advanced Solid Cancers

Interventions

Type	Name	Description
DRUG	ADI PEG20	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.
DRUG	Pembrolizumab	Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

Timeline

• Start date: 2017-07-14
• Primary completion: 2019-05-07
• Completion: 2020-02-25
• First posted: 2017-08-18
• Last updated: 2022-04-27

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study