About the RTX-224 Clinical Trial

Participating in a clinical trial is a significant commitment.
We are grateful for the important contributions of the volunteers who take part in this important research.

About the RTX-224
Phase 1/2 Clinical Trial

This Phase 1/2 clinical trial is designed to establish whether RTX-224 administered as a monotherapy is safe, how much RTX-224 needs to be given for it to be effective, and if RTX-224 has anti-tumor activity against the cancer. The trial seeks to evaluate:

Any side effects associated with RTX‑224
Preliminary dose, meaning how much RTX-224 needs to be given for it to be effective

All study participants
receive at no cost:

The study drug, study-related services, supplies, procedures, and care performed as part of this study and not part of your routine medical care will be paid for by the study site, through the study Sponsor.

Who can participate?

Upon reviewing the clinical trial eligibility criteria, speak with your doctor about any questions you may have and clinical trials that may benefit you.

Adults who meet the following criteria may be able to participate in the trial.

Men and women aged 18 or older with non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) cancer, or triple-negative breast cancer that has relapsed following or has been refractory, or has not responded to treatment or returned following treatment or is locally advanced or cannot be removed through surgery for which no standard therapy exists, or for which the patient is ineligible or has declined standard therapy.
Participants must have completed prior therapy, including radiation, at least 28 days prior to study treatment.
Prior therapy must have included the following:
- Non-small cell lung cancer: Patients must have experienced disease progression following platinum-containing chemotherapy and a programmed cell death 1 (PD-1) or programmed death-ligand 1 (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.
- Head and neck squamous cell carcinoma: Patients must have experienced disease progression following platinum-based combination chemotherapy and a PD-1 or PD-L1 inhibitor.
- Urothelial carcinoma: Patients must have experienced disease progression following platinum-based combination chemotherapy and a PD-1 or PD-L1 inhibitor.
- Triple-negative breast cancer: 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.
For females of reproductive potential, agreement to use highly effective contraceptive throughout and for six months following last dose study treatment.

What to expect if you are enrolled

Screening and Eligibility
(Up to 28 Days Prior to Receiving a Dose of RTX-224)

Participants in the trial will undergo:

A doctor’s exam
Blood tests
CT scans
Heart examination (Echo, ECG)

First Treatment
(Cycle One)

Patients will receive RTX-224 until the time in which the disease progresses or undesirable toxicities occur.
During the first week of cycle one, patients will come in for the first three days, and then weekly for the rest of the cycle.

Cycles Two and Beyond

In cycle two, after the first three days, weekly visits are required.
In subsequent cycles after cycle two, patients come in on day one of dosing and day three, followed by weekly visits.
Dosing days take approximately four to six hours, with subsequent visits to take approximately one hour.

Cancer Trial FAQs

Trial site locations

HonorHealth

Scottsdale, Arizona,

United States, 85258

Contact: Allison Miller
alyoung@honorhealth.com

Sarah Cannon Research Institute

Nashville, Tennessee,

United States, 37203

Contact: Sarah Cannon Research Contact
asksarah@sarahcannon.com

Virginia Cancer Specialists

Fairfax, Virginia,

United States, 22031

Contact: Frances Gatlin, BSN

703-280-5390

fgatlin@nextoncology.com

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