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

Completed · Phase 1

Conditions studied: Melanoma, Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02285101

Run by

Bio-Cancer Treatment International Limited

People needed

23

Starts

2014-11-01

Expected to finish

2019-02-01

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Stage IIIb/IV malignant melanoma or castration resistant adenocarcinoma of prostate (CRPC).
• Advanced cancer not candidate for treatment with modality or agents that are approved or have established efficacy. Candidates who cannot tolerate standard treatment or whose cancers have progressed on current standard of care.
• Males or females 18 years-old and above.
• Ability to understand and willingness to provide written informed consent;
• Karnofsky performance status (see Appendix 13.3) of 80% or above and expected survival of more than 12 weeks.
• Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period whether the patient is male or female.

You may not qualify if…

• Has received cancer treatment, e.g. chemotherapy, targeted biologic or enzymes, either approved or investigational, within 4 weeks prior to the start of the PEG-BCT-100;
• Advancing liver failure indicated by uncontrolled ascites, pleural effusions, or encephalopathy.
• Child-Pugh score of B and C (see Appendix 13.4).
• Significant hepatic, renal or bone marrow dysfunction indicated by: total bilirubin >2.0 mg/dL, evidence of bile duct obstruction, serum albumin <2.5 g/dL, serum ALT or AST >2.5 x upper limit of normal, serum creatinine ≥1.5 mg/dL, ANC ≥1.5 x 109/L, platelets <100 x 109/L, or INR >2.0.
• Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV (see Appendix 13.5), left ventricular ejection fraction (LVEF) lower than institutional normal limits by echo or MUGA, history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG.
• Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Significant active infection including HIV requiring oral or parenteral anti-infective therapies.
• Use of investigational drug(s) within 4 weeks of enrollment.
• Prior treatment with arginine depleting agent.

Where it is running

• California Cancer Associates for Research and Excellence, cCARE — San Diego, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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