Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer

Phase 1/2 Withdrawn Immune System Key Ltd

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1b, open-label, non-randomized, Dose Confirmation study. Subjects will be treated, once a week, with IV doses of Nerofe and low dose (20 mg/m2) Doxorubicin (6-8 hours from one another) in consecutive, 28-day cycles.

Timeline

Start: 2018-09-06
Primary completion: 2020-04-21
Completion: 2020-04-21

Outcome

Outcome not reported

Stopped (Enrollment): “Patients were screened but not enrolled”

Publications

Results Stemmer SM, Benjaminov O, Silverman MH, Sandler U, Purim O, Sender N, Meir C, Oren-Apoteker P, Ohana J, Devary Y. A phase I clinical trial of dTCApFs, a derivative of a novel human hormone peptide, for the treatment of advanced/metastatic solid tumors. Mol Clin Oncol. 2018 Jan;8(1):22-29. doi: 10.3892/mco.2017.1505. Epub 2017 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nerofe	Peptide	96 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	10 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	20 mg/m2	Intravenous