Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05661201

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Led by Georgetown University · Updated on 2026-03-06

24

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

I

Immune System Key Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced/unresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin. Participants will receive weekly doses of NEROFE and doxorubicin.

CONDITIONS

Official Title

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have an advanced, unresectable, or metastatic solid tumor with a confirmed KRAS mutation by standard testing methods
  • Tumor must express ST2 as confirmed by immunochemistry
  • Disease progressed on or intolerant to all standard therapies, or patient declined available standard therapies
  • Have received no more than two prior lines of systemic therapy for advanced disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Absolute neutrophil count of 1500/mm3 or higher
  • Hemoglobin level of 9.0 g/dL or higher (transfusions allowed to meet this)
  • Platelet count of 100 x 10^9/L or higher (transfusions not allowed to meet this)
  • Creatinine clearance of 50 mL/min/1.73 m2 or higher
  • AST and ALT levels up to 3 times the upper normal limit (higher if liver metastases present)
  • Total bilirubin up to 1.5 times the upper normal limit (higher if liver metastases present)
  • Partial Thromboplastin Time (PTT) no more than 1.5 times the upper normal limit and INR less than 1.5; patients on anticoagulation allowed if INR is therapeutic
  • Fully recovered from effects of surgery; at least 2 weeks after minor surgery and 4 weeks after major surgery before starting treatment
  • Women of childbearing potential must have a negative pregnancy test within 14 days before treatment; postmenopausal women must have been amenorrheic for at least 12 months
  • Able to understand and comply with study requirements and provide informed consent
  • Have measurable disease by RECIST v1.1 criteria
  • Disease suitable for repeated core tumor biopsies
  • Have stable venous access suitable for blood sampling, preferably a central line such as a portacath or PICC
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Prior treatment with anthracycline chemotherapy
  • Receiving any other active anti-cancer therapy during the study treatment
  • Brain metastases unless treated with surgery or radiation at least 4 weeks before treatment and no active disease seen on MRI
  • Received anti-tumor therapy within 3 weeks before starting study treatment
  • Severe or uncontrolled medical conditions that pose safety risks
  • Pregnant or breastfeeding women
  • Concurrent use of an aromatase inhibitor
  • Psychiatric or social conditions that would limit study compliance
  • Another malignancy within 2 years before study drug start, except certain treated skin cancers or cervical cancer
  • Active hepatitis B, C, or HIV unless controlled with undetectable viral load and adequate immune status
  • Significant uncontrolled heart disease or cardiac abnormalities including recent heart events, heart failure, low left ventricular ejection fraction, serious arrhythmias, prolonged QT interval, or blood pressure outside specified limits

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

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Research Team

E

Emmy Mckissick

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors | DecenTrialz