RTX-224 Monotherapy in Patients With Solid Tumors

Brief Title

RTX-224 Monotherapy in Patients With Solid Tumors

Official Title

A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors

Brief Summary

      This is an open-label, multidose, first-in-human (FIH), Phase 1/2 study of RTX-224 for the
      treatment of patients with relapsed or refractory (R/R), or locally advanced solid tumors.

Detailed Description

      This is a Phase 1, open label, multicenter, multidose, first-in-human (FIH), dose escalation
      and expansion to determine the safety and tolerability, recommended phase 2 dose, and
      pharmacology, and antitumor activity of RTX-224 in adult patients with persistent, recurrent,
      or metastatic, unresectable solid tumors. The study will include a monotherapy dose
      escalation phase followed by an expansion phase.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Safety Assessment by rate of Adverse Events (AEs)

Secondary Outcome

 Pharmacodynamics (PD) of RTX-224

Condition

Non Small Cell Lung Cancer

Intervention

RTX-224

Study Arms / Comparison Groups

 RTX-224 Dose Escalation

Description:  Phase 1: RTX-224 monotherapy dose escalation in Solid Tumors, administered intravenously on Day 1 of each cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 12, 2022

Completion Date

November 30, 2022

Primary Completion Date

November 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent obtained prior to study procedures Patients ≥18 years
             with an ECOG of 0 or 1

          -  R/R, or locally advanced, unresectable, and histologically or cytologically confirmed

             (a) NSCLC, (b) cutaneous melanoma, (c) HNSCC, (d) UC, or (e) TNBC, which are
             refractory to or otherwise ineligible for treatment with standard-of-care treatments

          -  Prior therapy in each disease setting must include the following:

               -  NSCLC: Patients must have experienced disease progression following
                  platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Patients with
                  EGFR, ALK, ROS-1, or other actionable mutations should have previously received
                  or been ineligible for therapies targeting their respective mutation(s).

               -  Cutaneous melanoma: Patients must have experienced disease progression following
                  a PD-1 or PD-L1 inhibitor. Patients with V600E mutations should have previously
                  received or been ineligible for approved BRAF inhibitor or MEK inhibitor therapy.

               -  HNSCC: Patients must have experienced disease progression following
                  platinum-based combination chemotherapy and a PD-1 or PD-L1 inhibitor.

               -  UC: Patients must have experienced disease progression following platinum-based
                  combination chemotherapy and a PD-1 or PD-L1 inhibitor.

               -  TNBC: Patients must have experienced disease progression following single-agent
                  or combination chemotherapy. Patients with BRCA1/2 mutations should have
                  previously received or been ineligible for an approved PARP inhibitor; patients
                  who are PD-L1 positive should have received or been ineligible for an approved
                  PD-1 or PD-L1 inhibitor.

          -  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 as Defined by the protocol:

               -  AST and ALT ≤3 × the upper limit of normal (ULN) Except in documented cases of
                  Gilbert syndrome, total bilirubin ≤1.5 × ULN

               -  Serum albumin ≥2.5 g/dL

               -  Serum or plasma creatinine ≤1.5 × ULN and/or glomerular filtration rate ≥50
                  mL/min/1.73 calculated by the Cockcroft-Gault formula

               -  Absolute neutrophil count ≥1 × 103/μL

               -  Platelet count ≥100 × 103/μL

               -  Hemoglobin ≥9 g/dL

        Exclusion Criteria:

          -  Patient has central nervous system (CNS) involvement. If the patient fulfills the
             following 3 criteria, she/he is eligible for the trial after consultation with the
             Sponsor Medical Monitor.

          -  Completed prior therapy for CNS metastases (radiation and/or surgery)

          -  CNS tumor(s) is clinically stable at the time of enrollment

          -  Patient does not require corticosteroid or antiepileptic therapy for management of CNS
             metastases

          -  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).

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT05219578

Organization ID

RTX-224-01

Responsible Party

Sponsor

Study Sponsor

Rubius Therapeutics

Study Sponsor

, ,

Verification Date

December 2022