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Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

NCT03634150•Immune System Key Ltd

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 90 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Females over18 years of age.
•2. Pathologically confirmed locally advanced and/or metastatic solid tumor, for which, in the judgment of the Principal Investigator, no standard curative therapy exists.
•3. Subjects must have 1 of the following solid tumor types: Ovarian cancer (up to 12 patients), or by Triple-negative breast cancer (up to 12 patients).
•4. Disease that is evaluable, or measurable on imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1 Appendix A), and where applicable is characterized by informative tumor marker(s).
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2(Section 6.1.1.6) .
•6. Acceptable clinical laboratory values at screening, as indicated by:
•Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 75,000/mm3; Total bilirubin ≤ 5 mg/dL. ASpartate aminoTransferase (SGOT) ≤ 2.5 × the Upper Limit of Normal; ALalanine aminoTransferase (SGPT) ≤ 2.5 × the Upper Limit of Normal; Serum creatinine ≤ 1.5 mg/dL or a measured creatinine clearance higher than 60 mL/min; and Negative serum Beta human chorionic gonadotropin test in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study entry).
•7. Patients with hepatic metastasis are eligible to enroll, provided that the following criteria are met at Screening:
•Total bilirubin ≤ 5 \* mg/dL; ASpartate aminoTransferase and ALalanine aminoTransferase are each ≤ 5 × the Upper Limit of Normal;
•8. Willing and able to provide written Informed Consent and comply with the requirements of the study.
+2 more criteria

Exclusion Criteria

•1. Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 1 month prior to Baseline and remains stable during the trial), immunosuppressive therapy, corticosteroids \> 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.
•2. Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI CTCAE v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
•3. Receipt of \>3 prior regimens of cytotoxic chemotherapy, including any use in the neo-adjuvant, adjuvant, and/or metastatic settings ,Unless more than 1 year elapsed since the Neo-adjuvant treatment was completed
•4. Receipt of Blood Transfusion during 2 weeks prior to Baseline
•5. Life expectancy \<12 weeks.
•6. Major surgery or radiation therapy within 28 days prior to initiation of study drug,
•7. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness.
•8. Patients with history of brain metastasis
•9. Known active hepatitis B or C or other active liver disease (other than malignancy).
•10. Severe liver dysfunction (Child-Pugh Class B or C) and
+14 more criteria

Locations (1)

Oncologic Institue, Kaplan

Rehovot, Israel

Key Dates

Start Date

September 6, 2018

Primary Completion Date

April 21, 2020

Completion Date

April 21, 2020

Last Updated

October 26, 2021

Conditions

Metastatic Ovarian CancerTriple Negative Breast Cancer

Interventions

Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.

BIOLOGICAL

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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