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

NCT03634150 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

Interventions

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) .

Sponsors & Collaborators

  • Immune System Key Ltd

    lead INDUSTRY

Principal Investigators

  • Yoram Devary, phd · Immune System Key Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

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 NCT03634150 on ClinicalTrials.gov