RTX-224 Monotherapy in Patients With Solid Tumors
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.
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This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 9, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Rubius Therapeutics
- Interventions being studied
- Drug: RTX-224
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealthScottsdale, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- University of California San Francisco HealthSan Francisco, California
- Sarah Cannon Research InstituteNashville, Tennessee
- Virginia Cancer SpecialistsFairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 9, 2022. Always confirm current availability with the study team.