RTX-240 Monotherapy and in Combination With Pembrolizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Solid Tumor, AML Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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RTX-240

Engineered red cells co-expressing 4-1BBL and IL-15TP

Intervention Type DRUG

Pembrolizumab

Humanized immunoglobulin G4 programmed death receptor-1 blocking antibody

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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United States

Other Identifiers

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RTX-240-01

Identifier Type: -

Identifier Source: org_study_id

RTX-240 Monotherapy and in Combination With Pembrolizumab

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Part 1: RTX-240 Dose Escalation

RTX-240

Part 2: RTX-240 Solid Tumor Expansion

RTX-240

Part 3: RTX-240 Dose Escalation

RTX-240

Part 4: RTX-240 Plus Pembrolizumab Dose Escalation

RTX-240

Pembrolizumab

Interventions

RTX-240

Pembrolizumab

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Rubius Therapeutics

Responsible Party

Locations

University of California San Diego

The Angeles Clinic & Research Institute

Sarah Cannon Research Institute/ Colorado Blood Cancer Institute

Sylvester Comprehensive Cancer Center/UMHC

Massachusetts General Hospital

Columbia University Medical Center

Oregon Health & Sciences University - Knight Cancer Institute

Thomas Jefferson University

UPMC Hillman Cancer Center

Sarah Cannon Research Institute

Virginia Cancer Specialists

Countries

Other Identifiers

RTX-240-01