Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Non Small Cell Lung Cancer, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, TNBC - Triple-Negative Breast Cancer, Solid Tumor, Advanced Solid Tumors, Carcinoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, RTX-224

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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).

Locations

  • University of California San Francisco Health
    San Francisco California 94143 United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rubius Therapeutics
ID
NCT05219578
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 128 study participants
Last Updated