Non Small Cell Lung CancerPhase 1/2NCT05219578
RTX-224 Monotherapy in Patients With Solid Tumors
A Phase 1/2 study testing RTX-224 in people with Non Small Cell Lung Cancer and Cutaneous Melanoma, run by Rubius Therapeutics at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- RTX-224
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Jan 2022to 30 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
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- 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
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Virginia Cancer Specialists
Fairfax, Virginia, 22031
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of California San Francisco Health
San Francisco, California, 94143
HonorHealth
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced 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.
Read the 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
- Being tested
- RTX-224
- Keywords
- Solid Tumor, Advanced Solid Tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTX-224Drug
RTX-224 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| RTX-224 Dose Escalation | Experimental | Phase 1: RTX-224 monotherapy dose escalation in Solid Tumors, administered intravenously on Day 1 of each cycle. Receives: Drug: RTX-224 |
| RTX-224 Dose Expansion | Experimental | Phase 2: RTX-224 monotherapy dose expansion in Solid Tumors, administered intravenously on Day 1 of each cycle. Receives: Drug: RTX-224 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment by rate of Adverse Events (AEs)
Measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: up to 30 months
Dose limiting toxicities (DLTs) of RTX-224
As determined by incidence and severity of adverse events
Measured: up to 30 months
Secondary outcomes (8)
Pharmacodynamics (PD) of RTX-224
As measured by the changes in immune cell populations, e.g., T cells and NK cells
Measured: up to 30 months
Pharmacokinetics (PK) of RTX-224
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.
Measured: up to 30 months
Pharmacokinetics (PK) of RTX-224
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.
Measured: up to 30 months
Anti-tumor activity of RTX-224
As measured by duration of response (DoR)
Measured: up to 30 months
Anti-tumor activity of RTX-224
As measured by overall survival (OS)
Measured: up to 30 months
Anti-tumor activity of RTX-224
As measured by progression free survival (PFS)
Measured: up to 30 months
Anti-tumor activity of RTX-224
As measured by disease control rate (DCR)
Measured: up to 30 months
Anti-tumor activity of RTX-224
As measured by objective response rate (ORR)
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start12 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rubius Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219578
- Sponsor's protocol ID
- RTX-224-01
- Status last verified
- Dec 2022
- First submitted
- 6 Jan 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05219578
- Acronym / sponsor ID
- RTX-224-01
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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).
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rubius TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTX-224 Dose Escalation | Experimental | Drug: RTX-224Phase 1: RTX-224 monotherapy dose escalation in Solid Tumors, administered intravenously on Day 1 of each cycle. |
| RTX-224 Dose Expansion | Experimental | Drug: RTX-224Phase 2: RTX-224 monotherapy dose expansion in Solid Tumors, administered intravenously on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Prior therapy in each disease setting must include the following:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTX-224RTX-224 monotherapy | Drug | RTX-224 Dose Escalation, RTX-224 Dose Expansion |
Primary outcome
Safety Assessment by rate of Adverse Events (AEs)
Time frame: up to 30 months
Measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Dose limiting toxicities (DLTs) of RTX-224
Time frame: up to 30 months
As determined by incidence and severity of adverse events
8 secondary outcomes
Pharmacodynamics (PD) of RTX-224
Time frame: up to 30 months
Pharmacokinetics (PK) of RTX-224
Time frame: up to 30 months
Pharmacokinetics (PK) of RTX-224
Time frame: up to 30 months
Anti-tumor activity of RTX-224
Time frame: up to 30 months
Anti-tumor activity of RTX-224
Time frame: up to 30 months
Anti-tumor activity of RTX-224
Time frame: up to 30 months
Anti-tumor activity of RTX-224
Time frame: up to 30 months
Anti-tumor activity of RTX-224
Time frame: up to 30 months
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RTX-224 in people with Non Small Cell Lung Cancer and Cutaneous Melanoma, run by Rubius Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment by rate of Adverse Events (AEs) (time frame: up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.