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RTX-240 Monotherapy and in Combination With Pembrolizumab

R

Rubius Therapeutics

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Solid Tumor, AML Adult

Treatments

Drug: RTX-240
Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04372706
RTX-240-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ≥ 1 × 10^3/μL without myeloid growth factor support for at least one week prior to enrollment
    • Platelet count ≥ 75 × 10^3/μL
    • Hemoglobin should be ≥ 9 g/dL without red blood cell transfusion for at least one week
    • Patients must have LVEF ≥ 45%
  • Patients enrolling into Part 2 of the study must be diagnosed with NSCLC, RCC, or anal cancers

  • Patients enrolling into Part 4 must be diagnosed with NSCLC or RCC

  • Patients enrolling into either Part 2 or 4 must have 2 or fewer prior treatment regimens. If patient received a prior PD-1/PD-L1-containing regimen, a prior response is required.

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
  • Class III or IV cardiomyopathy per the New York Heart Association criteria
  • Leukemic blast count ≥ 25 x 10^3/µL (Part 3)
  • Concomitant conditions requiring active immunosuppression
  • History of clinically significant Grade 3 or higher 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 Grade 2 or greater immune related pneumonitis, hepatitis, hypophysitis, or other endocrinopathy (Part 4)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

69 participants in 4 patient groups

Part 1: RTX-240 Dose Escalation
Experimental group
Description:
Phase 1: RTX-240 monotherapy dose escalation in Solid Tumors
Treatment:
Drug: RTX-240
Part 2: RTX-240 Solid Tumor Expansion
Experimental group
Description:
Phase 2: RTX-240 monotherapy dose expansion in Non-small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC), and anal cancers
Treatment:
Drug: RTX-240
Part 3: RTX-240 Dose Escalation
Experimental group
Description:
Phase 1: RTX-240 monotherapy dose escalation in AML
Treatment:
Drug: RTX-240
Part 4: RTX-240 Plus Pembrolizumab Dose Escalation
Experimental group
Description:
Phase 1: RTX-240 dose escalation in combination with Pembrolizumab in Solid Tumors
Treatment:
Drug: Pembrolizumab
Drug: RTX-240

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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