NCT03634150

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

A Phase 1b, Open-Label, Dose-Confirmation Study Evaluating the Safety, and Clinical Effects of Intravenously Administered Nerofe™ in Combination With Doxorubicin, In Subjects With Metastatic Ovarian Cancer and Triple Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Immune System Key Ltd · Industry
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will be evaluated regularly for safety. Subjects will return for a follow-up visit 30-33 days after the last dosing of study drug. Subjects who tolerate the drug and who do not experience progressive disease, intolerable toxicity, or meet any of the other withdrawal criteria - may continue to receive Nerofe \& Doxorubicin for up to 5 cycles, at the discretion of the Principal Investigator. Throughout the trial, oversight will be provided by the Clinical Safety Committee (CSC).

Conditions

• Metastatic Ovarian Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.	Once weekly treatment, with IV doses of Nerofe (96mg\\m2) and low dose (20 mg/m2) Doxorubicin 5 or 24 hours from one another) .

Timeline

• Start date: 2018-09-06
• Primary completion: 2020-04-21
• Completion: 2020-04-21
• First posted: 2018-08-16
• Last updated: 2021-10-26

Locations

1 site across 1 country: Israel