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Anti-tumor antibiotic

NEROFE + Doxorubicin for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks until progression, approximately 6 months
Awards & highlights

Summary

This trial will test the safety and effectiveness of a combination of drugs to treat advanced/metastatic KRAS-mutated and ST-positive tumors. Patients will be given weekly doses to find the best dose and schedule.

Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and which have a specific KRAS mutation and ST2 expression. Participants must have tried all standard treatments or chosen not to use them, and should not be pregnant or breastfeeding. They need normal liver function (with some leeway if they have liver metastases), no serious heart conditions, controlled blood pressure, no brain metastases unless treated and stable, and cannot be on certain medications.Check my eligibility
What is being tested?
The study tests the safety of NEROFE combined with doxorubicin in treating solid tumors with specific genetic features. It aims to find the best dose schedule for this combination therapy. Patients will receive weekly doses of both drugs while their health is closely monitored.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, heart problems given doxorubicin's known effect on the heart muscle; plus any additional risks related to NEROFE which are being studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks until progression, approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks until progression, approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse events meeting protocol defined dose limiting toxicities
Incidence of Serious Adverse events
Incidence of adverse events
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Pharmacodynamics: Change in KRAS mRNA
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose level 2: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 192 mg/m2, intravenously over 60 minutes
Group II: Dose level -1: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 48 mg/m2, intravenously over 60 minutes
Group III: Dose Level 3: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 288 mg/m2, intravenously over 60 minutes
Group IV: Dose Level 1: NEROFE with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 96 mg/m2, intravenously over 60 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Doxorubicin, a common treatment for tumors, works by intercalating into DNA and inhibiting topoisomerase II, which disrupts DNA replication and transcription, leading to cancer cell death. This is important for tumor patients as it directly targets and reduces the growth of rapidly dividing cancer cells. Understanding these mechanisms aids in developing effective combination therapies, such as those involving NEROFE and doxorubicin, to improve treatment outcomes and manage resistance.
Anthracycline drug targeting: cytoplasmic versus nuclear--a fork in the road.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
345 Previous Clinical Trials
137,342 Total Patients Enrolled
1 Trials studying Tumors
10 Patients Enrolled for Tumors
Immune System Key LtdIndustry Sponsor
4 Previous Clinical Trials
41 Total Patients Enrolled
Benjamin Weinberg, MDStudy ChairGeorgetown University
5 Previous Clinical Trials
173 Total Patients Enrolled

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05661201 — Phase 1
Tumors Research Study Groups: Dose Level 1: NEROFE with doxorubicin, Dose level 2: Nerofe with doxorubicin, Dose level -1: Nerofe with doxorubicin, Dose Level 3: Nerofe with doxorubicin
Tumors Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT05661201 — Phase 1
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05661201 — Phase 1
~13 spots leftby Jan 2026