Clinical Trials /

RTX-240 Monotherapy

NCT04372706

Description:

Open label, multicenter, multidose, first-in-human Phase 1/2 study of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: RTX-240 Monotherapy
  • Official Title: Phase 1/2 Study of RTX-240 Monotherapy

Clinical Trial IDs

  • ORG STUDY ID: RTX-240-01
  • NCT ID: NCT04372706

Conditions

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
RTX-240Part 1: RTX-240 Dose Escalation

Purpose

Open label, multicenter, multidose, first-in-human Phase 1/2 study of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.

Detailed Description

      This is a Phase 1/2, open label, multicenter, multidose, first-in-human (FIH) dose escalation
      and expansion 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 or locally advanced solid tumors. 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
      harnessing the innate and adaptive immune systems for the treatment of cancer. The study will
      include a monotherapy dose escalation phase followed by an expansion phase in specified tumor
      types.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: RTX-240 Dose EscalationExperimentalPhase 1: RTX-240 administered intravenously on Day 1 of each cycle.
  • RTX-240
Part 2: RTX-240 Solid Tumor ExpansionExperimentalPhase 2: RTX-240 administered intravenously on Day 1 of each cycle.
  • RTX-240

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent obtained prior to study procedures

          -  Patients ≥18 years with an ECOG 0 or 1.

          -  Relapsed/Refractory or locally advanced, unresectable solid tumor for which no
             standard therapy exists, or for which the patient is ineligible or has declined
             standard therapy.

          -  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.

          -  Positive antibody screen using institution's standard type and screen test

          -  Adequate Organ Function 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

        Exclusion Criteria:

          -  Primary CNS malignancy or central nervous system (CNS) involvement, unless
             asymptomatic, previously treated, and stable without steroids.

          -  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

          -  Concomitant conditions requiring active immunosuppression

          -  Grade 3 immune related Adverse Event (irAE)

          -  Prior malignancy within the past 3 years, with protocol specified exceptions
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety Assessment: Measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame:Up to 38 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:PK of RTX-240 as measured by detection of the number of RTX cells positive for both 4-1BBL and IL-15 using flow cytometry.
Time Frame:Assessed From the 1st dose of RTX-240 until 30 days after last of study treatment
Safety Issue:
Description:
Measure:Determination of the Immunogenicity of RTX-240 Measured by the incidence of antibodies to RTX-240
Time Frame:Assessed From the 1st dose of RTX-240 until 30 days after last of study treatment
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by clinical benefit rate (CBR) (% of patients who achieve CR, PR or SD)
Time Frame:Up to 38 months
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by duration of response (DoR)
Time Frame:Up to 38 months
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by progression free survival (PFS)
Time Frame:Up to 38 months
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by overall survival (OS)
Time Frame:Up to 38 months
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by time to response (TTR).
Time Frame:Up to 38 months
Safety Issue:
Description:
Measure:Anti-tumor activity of RTX-240 measured by time to progression (TTP)
Time Frame:Up to 38 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Rubius Therapeutics

Last Updated

April 29, 2020