Testing TORL-3-600 in patients with advanced cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
This study is testing a new drug called TORL-3-600 to see if it can help people with advanced cancer feel better and fight their tumors.
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 | 8 sites (Fullerton, California and 7 other locations) |
| Trial ID | NCT05948826 on ClinicalTrials.gov |
What this trial studies
This first-in-human study aims to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of a new drug called TORL-3-600 in patients diagnosed with advanced solid tumors, including colorectal cancer. Participants will be monitored for their response to the treatment and any side effects experienced. The study will include patients with measurable disease and adequate organ function, while excluding those with certain medical histories or conditions that may interfere with the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with advanced solid tumors who have measurable disease and a good performance status.
Not a fit: Patients with significant cardiac disease, uncontrolled infections, or those who have received 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-3-600 * 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
Fullerton, California and 7 other locations
- Providence Medical Foundation — Fullerton, California, United States (Recruiting)
- UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (Recruiting)
- Sarah Cannon Research Institute — Denver, Colorado, United States (Recruiting)
- Fort Wayne Medical Oncology and Hematology Inc. — Fort Wayne, Indiana, United States (Recruiting)
- Washington University School of Medicine-Siteman Cancer Center — Saint Louis, Missouri, United States (Recruiting)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Recruiting)
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Brandon Sookdeo
- Email: brandon.sookdeo@torlbio.com
- Phone: 909-333-8966
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.