Status:
TERMINATED
RTX-240 Monotherapy and in Combination With Pembrolizumab
Lead Sponsor:
Rubius Therapeutics
Conditions:
Solid Tumor, AML Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 a...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04372706
Start Date
May 6 2020
End Date
November 30 2022
Last Update
December 13 2022
Active Locations (11)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
3
Sarah Cannon Research Institute/ Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
4
Sylvester Comprehensive Cancer Center/UMHC
Miami, Florida, United States, 33136