Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

NCT ID: NCT03254732

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2020-02-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADI-PEG 20

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.

Group Type: EXPERIMENTAL

ADI PEG20

Intervention Type: DRUG

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

Intervention Type: DRUG

Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

Interventions

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.

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

Intervention Type: DRUG

Other Intervention Names

Keytruda®

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed diagnosis of advanced solid tumor.

2. Prior failure of a systemic treatment approved by the health authority in the country where the study will be enrolling. Such subjects may also have been treated with radiotherapy, local therapy or surgery.

3. Measurable disease using RECIST 1.1 criteria.

4. Age ≥ 18 years.

Exclusion Criteria

1. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.

2. Subjects who had been treated with ADI-PEG 20 previously.

3. History of seizure disorder not related to underlying cancer.

4. Known allergy to pegylated compounds.

5. Known allergy to E. coli drug products (such as GMCSF).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polaris Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Facility National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

POLARIS2016-002

Identifier Type: -

Identifier Source: org_study_id