NCT05661201

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• KRAS Mutation-Related Tumors

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2023-04-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-12-22
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study