Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

Phase 1/2 Study of RTX-240 Monotherapy

Details

This is a Phase 1/2, open label, multicenter, multidose, first-in-human (FIH) dose escalation and expansion 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 or locally advanced solid tumors (Phase 1/2) or relapsed/refractory acute myeloid leukemia (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 harnessing the innate and adaptive immune systems for the treatment of cancer. The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types.

Keywords

Solid Tumor, AML Adult RTX-240

Eligibility

You can join if…

Open to people ages 18 years and up

  • Signed written informed consent obtained prior to study procedures
  • Patients ≥18 years with an ECOG 0 or 1 (Parts 1 and 2) or 0-2 (Part 3).
  • Relapsed/Refractory (R/R) or locally advanced, unresectable solid tumor for which no standard therapy exists (Parts 1 and 2), or for which the patient is ineligible or has declined standard therapyR/R, cytologically confirmed AML (Part 3).
  • Disease must be measurable per Response Evaluation Criteria
  • The shorter of 28 days or 5 half-lives must have elapsed since the completion of prior therapy, before initiation of study treatment.
  • Adequate Organ Function as Defined by the protocol:
  • GFR ≥ 50 mL/min/1.73,
  • AST and ALT ≤ 3 × the ULN and total bilirubin ≤ 1.5 × ULN,
  • In the absence of cancer within the liver, or AST and ALT ≤ 5 × ULN and total bilirubin ≤ 3 × ULN, in the setting of primary or metastatic liver tumors.
  • ANC ≥ 10 × 103/μL and platelet count ≥ 100 × 103/μL without myeloid growth factor support or transfusion, respectively, for at least one week.
  • Hemoglobin should be ≥ 9 g/dL without red blood cell transfusion for at least two weeks.
  • Patients must have LVEF ≥ 45%
  • Patients enrolling into Part 2 of the study must be diagnosed with a solid tumor that has been selected for an expansion cohort

You CAN'T join if...

  • Primary central nervous system (CNS) malignancy or CNS involvement, unless asymptomatic, previously treated, and stable without steroids (Parts 1 and 2) or known CNS leukemia (Part 3).
  • Known hypersensitivity to any component of study treatment or excipients.
  • Positive antibody screen using institution's standard type and screen test.
  • Clinically significant, active and uncontrolled infection, including human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • Clinically significant coagulopathy, uncontrolled hypertension or autoimmune hemolytic anemia
  • Leukemic blast count ≥25 x 103/µL (Part 3)
  • Concomitant conditions requiring active immunosuppression
  • Grade 3 immune related Adverse Event (irAE)
  • Prior malignancy within the past 3 years, with protocol specified exceptions

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • The Angeles Clinic & Research Institute accepting new patients
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rubius Therapeutics
ID
NCT04372706
Phase
Phase 1/2
Study Type
Interventional
Last Updated