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RECRUITING
NCT05661201
PHASE1

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

Sponsor: Georgetown University

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I Study of NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-04-12

Completion Date

2027-01

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

NEROFE

weekly doses of NEROFE (48-288 mg/m2) (dose level 1: 96 mg/m2, dose level -1: 48 mg/m2, dose level 2: 192 mg/m2, dose level 3: 288 mg/m2), intravenously over 60 minutes

DRUG

Doxorubicin

weekly doses of 8 mg/m2 (fixed dose), intravenous push over 3 mins;

Locations (1)

Georgetown Lombardi Comprehensive Cancer Center

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