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).
Phase 1/2 Study of RTX-240 Monotherapy
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.
Solid Tumor, AML Adult RTX-240
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
- 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
- accepting new patients
- Start Date
- Completion Date
- Rubius Therapeutics
- Phase 1/2
- Study Type
- Last Updated
Please contact me about this study
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