NCT04372706

RTX-240 Monotherapy and in Combination With Pembrolizumab

Phase 1/2 Study of RTX-240 Monotherapy and in Combination With Pembrolizumab

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Rubius Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label, multicenter, multidose, first-in-human Phase 1/2 study of RTX-240 monotherapy or in combination of pembrolizumab for the treatment of patients with (1) relapsed/refractory R/R or locally advanced solid tumors (Phase 1/2) or (2) R/R Acute Myeloid Leukemia (AML) (Phase 1 only).

Detailed description

This is a Phase 1/2, open label, multicenter, multidose, first-in-human (FIH) dose escalation and expansion study to determine the safety and tolerability, recommended phase 2 dose and optimal dosing interval, pharmacology, and antitumor activity of RTX-240 in adult patients with relapsed/refractory (R/R) or locally advanced solid tumors (Phase 1/2) or R/R acute myeloid leukemia (Phase 1 only), and RTX-240 in combination with pembrolizumab in adult patients with R/R or locally advanced solid tumors (Phase 1 only). RTX-240 is a cellular therapy that co-expresses 4-1BBL and IL-15TP, a fusion of IL-15 and IL-15 receptor alpha, with the goal of stimulating the innate and adaptive immune systems for the treatment of cancer. The study includes a monotherapy dose escalation phase (Phase 1) followed by an expansion phase (Phase 2) in specified tumor types.

Conditions

• Solid Tumor, AML Adult

Interventions

Type	Name	Description
DRUG	RTX-240	Engineered red cells co-expressing 4-1BBL and IL-15TP
DRUG	Pembrolizumab	Humanized immunoglobulin G4 programmed death receptor-1 blocking antibody

Timeline

• Start date: 2020-05-06
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2020-05-04
• Last updated: 2022-12-13

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study