We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RTX-224 Monotherapy in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05219578
Recruitment Status : Terminated (The Sponsor terminated study after dosing 2 dose groups (7 pts) and closed trial on 11/30/22. RTX-224 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared rapidly (w/in 10 min).)
First Posted : February 2, 2022
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Rubius Therapeutics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Cutaneous Melanoma Head and Neck Squamous Cell Carcinoma Urothelial Carcinoma TNBC - Triple-Negative Breast Cancer Drug: RTX-224 Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors
Actual Study Start Date : January 12, 2022
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: RTX-224 Dose Escalation
Phase 1: RTX-224 monotherapy dose escalation in Solid Tumors, administered intravenously on Day 1 of each cycle.
 Drug: RTX-224
RTX-224 monotherapy
Experimental: RTX-224 Dose Expansion
Phase 2: RTX-224 monotherapy dose expansion in Solid Tumors, administered intravenously on Day 1 of each cycle.
 Drug: RTX-224
RTX-224 monotherapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety Assessment by rate of Adverse Events (AEs) [ Time Frame: up to 30 months ]
    Measured by incidence of Treatment Emergent Adverse Events (TEAEs)

  2. Dose limiting toxicities (DLTs) of RTX-224 [ Time Frame: up to 30 months ]
    As determined by incidence and severity of adverse events


Secondary Outcome Measures :
  1. Pharmacodynamics (PD) of RTX-224 [ Time Frame: up to 30 months ]
    As measured by the changes in immune cell populations, e.g., T cells and NK cells

  2. Pharmacokinetics (PK) of RTX-224 [ Time Frame: up to 30 months ]
    Maximum concentration (Cmax) of RTX-224 cells (positive for both 4-1BBL and IL-12 using flow cytometry) in blood after administration will be measured.

  3. Pharmacokinetics (PK) of RTX-224 [ Time Frame: up to 30 months ]
    Time to maximum concentration (tmax) of RTX-224 cells (positive for both 4-1BBL and IL-12 using flow cytometry) in blood after administration will be measured.

  4. Anti-tumor activity of RTX-224 [ Time Frame: up to 30 months ]
    As measured by duration of response (DoR)

  5. Anti-tumor activity of RTX-224 [ Time Frame: up to 30 months ]
    As measured by overall survival (OS)

  6. Anti-tumor activity of RTX-224 [ Time Frame: up to 30 months ]
    As measured by progression free survival (PFS)

  7. Anti-tumor activity of RTX-224 [ Time Frame: up to 30 months ]
    As measured by disease control rate (DCR)

  8. Anti-tumor activity of RTX-224 [ Time Frame: up to 30 months ]
    As measured by objective response rate (ORR)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219578


Locations
Layout table for location information
United States, Arizona
HonorHealth
Scottsdale, Arizona, United States, 85258
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
University of California San Francisco Health
San Francisco, California, United States, 94143
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Rubius Therapeutics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rubius Therapeutics
ClinicalTrials.gov Identifier: NCT05219578    
Other Study ID Numbers: RTX-224-01
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rubius Therapeutics:
Solid Tumor, Advanced Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms by Site
Carcinoma, Squamous Cell
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms