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Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors

NCT02285101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-04-24

No results posted yet for this study

Summary

The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as an infusion to treat patients who bear advanced solid tumors that are dependent on arginine (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have progressed after receiving approved or established therapies. This is a Phase 1 study; PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.

Conditions

Interventions

BIOLOGICAL

PEG-BCT-100

Sponsors & Collaborators

  • Oncotherapeutics

    collaborator INDUSTRY

  • Bio-Cancer Treatment International Limited

    lead INDUSTRY

Principal Investigators

  • Alberto Bessudo, MD · California Cancer Associates For Research and Excellence, cCARE

  • Steven O'Day, MD · Saint John's Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02285101 on ClinicalTrials.gov