MedTrace Logo

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

NCT03254732 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-04-27

No results posted yet for this study

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

Conditions

  • Advanced Solid Cancers

Interventions

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.

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2019-05-07
Completion
2020-02-25
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT03254732 on ClinicalTrials.gov