NCT05219578

RTX-224 Monotherapy in Patients With Solid Tumors

A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Rubius Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multidose, first-in-human (FIH), Phase 1/2 study of RTX-224 for the treatment of patients with relapsed or refractory (R/R), or locally advanced solid tumors.

Detailed description

This is a Phase 1, open label, multicenter, multidose, first-in-human (FIH), dose escalation and expansion to determine the safety and tolerability, recommended phase 2 dose, and pharmacology, and antitumor activity of RTX-224 in adult patients with persistent, recurrent, or metastatic, unresectable solid tumors. The study will include a monotherapy dose escalation phase followed by an expansion phase.

Conditions

• Non Small Cell Lung Cancer
• Cutaneous Melanoma
• Head and Neck Squamous Cell Carcinoma
• Urothelial Carcinoma
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	RTX-224	RTX-224 monotherapy

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-02-02
• Last updated: 2022-12-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study