RTX-240 Monotherapy and in Combination With Pembrolizumab

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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 AML (Phase 1 only).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rubius Therapeutics
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Signed written informed consent obtained prior to study procedures

• Patients ≥18 years with an ECOG 0 or 1 (Parts 1, 2 and 4) or 0-2 (Part 3).

• Relapsed/Refractory (R/R) or locally advanced, unresectable solid tumor for which no standard therapy exists (Parts 1, 2 and 4), or for which the patient is ineligible or has declined standard therapy or R/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 and Blood Cell Counts (Parts 1, 2, and 4) 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

• Patients must have LVEF ≥ 45%

• Patients enrolling into Part 4 must have relapsed following or have been refractory to a prior PD 1 or PD L1 blocking antibody.

Exclusion Criteria:

• Primary central nervous system (CNS) malignancy or CNS involvement, unless asymptomatic, previously treated, and stable without steroids (Parts 1, 2 and 4) 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

• History of severe hypersensitivity to a PD 1/PD L1 blocking Ab unless previously rechallenged successfully (Part 4)

• Current noninfectious pneumonitis or a history of radiation pneumonitis or pneumonitis that required steroids or greater immune related pneumonitis, hepatitis, hypophysitis, or other endocrinopathy (Part 4)