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

INTRODUCTION

  • Org Study ID: RTX-224-01
  • Secondary ID: N/A
  • NTC ID: NCT05219578
  • Sponsor: Rubius Therapeutics

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.

  • Overall Status
    Recruiting
  • Start Date
    January 12, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety Assessment by rate of Adverse Events (AEs)

Primary Outcome 1 - Timeframe: up to 30 months

Primary Outcome 2 - Measure: Dose limiting toxicities (DLTs) of RTX-224

Primary Outcome 2 - Timeframe: up to 30 months

CONDITION

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

ELIGIBILITY

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 617-679-9600

Email: gilad.gordan@rubiustx.com

LOCATION

Facility Status Contact
Facility: HonorHealth
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Allison Miller
703-280-5390
alyoung@honorhealth.com
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Stephanie Kim

Stephanie.kim2@med.usc.edu
Facility: University of California San Francisco Health
San Francisco, California 94143
United States
Status: Recruiting Contact: Contact
Marissa Gin

Marissa.Gin@ucsf.edu
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Sarah Cannon Research Contact

asksarah@sarahcannon.com
Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Frances Gatlin, BSN

fgatlin@nextoncology.com