RTX-224 Monotherapy in Patients With Solid Tumors

NCT ID: NCT05219578

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2022-11-30

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.

Conditions

Non Small Cell Lung Cancer; Cutaneous Melanoma; Head and Neck Squamous Cell Carcinoma; Urothelial Carcinoma; TNBC - Triple-Negative Breast Cancer

Keywords

Solid Tumor, Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RTX-224 Dose Escalation

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

Group Type: EXPERIMENTAL

RTX-224

Intervention Type: DRUG

RTX-224 monotherapy

RTX-224 Dose Expansion

Phase 2: RTX-224 monotherapy dose expansion in Solid Tumors, administered intravenously on Day 1 of each cycle.

Group Type: EXPERIMENTAL

RTX-224

Intervention Type: DRUG

RTX-224 monotherapy

Interventions

RTX-224

RTX-224 monotherapy

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rubius Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HonorHealth

Scottsdale, Arizona, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California San Francisco Health

San Francisco, California, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

RTX-224-01

Identifier Type: -

Identifier Source: org_study_id