Testing TORL-4-500 in patients with advanced cancer
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
This study is testing a new treatment called TORL-4-500 to see if it is safe and effective for people with advanced cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TORL Biotherapeutics, LLC Industry-sponsored |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT06005740 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced solid tumors, including hepatocellular carcinoma. The study will assess various advanced or metastatic solid tumor malignancies, focusing on measurable disease as defined by RECIST v1.1. Participants will receive the investigational treatment and undergo monitoring for any adverse effects and therapeutic responses.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced solid tumors who have measurable disease and meet specific health criteria.
Not a fit: Patients with uncontrolled medical conditions, significant cardiac history, or recent cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancer.
How similar studies have performed: While this is a first-in-human study, similar approaches in targeting advanced cancers have shown promise in other trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced solid tumor * Measurable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-4-500 * Progressive or symptomatic brain metastases * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * History of significant cardiac disease * History of myelodysplastic syndrome (MDS) or AML * History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded * If female, is pregnant or breastfeeding
Where this trial is running
Phoenix, Arizona and 9 other locations
- Mayo Clinic Phoenix — Phoenix, Arizona, United States (Recruiting)
- Providence Medical Foundation — Fullerton, California, United States (Recruiting)
- UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (Recruiting)
- Torrance Memorial Physician Network — Torrance, California, United States (Recruiting)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Florida Cancer Specialists Lake Nona Drug Development Unit — Orlando, Florida, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Virginia Cancer Specialists — Lexington, Virginia, United States (Recruiting)
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Caroline Labib, PharmD
- Email: caroline.labib@torlbio.com
- Phone: 310-348-9636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.