Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 Acute Myeloid Leukemia (AML)
(Phase 1 only).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
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)