Testing TORL-1-23 in patients with advanced cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
PHASE1 · TORL Biotherapeutics, LLC · NCT05103683
This study is testing a new treatment called TORL-1-23 to see if it can help people with advanced cancers like ovarian, endometrial, and lung cancer feel better and fight their disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TORL Biotherapeutics, LLC (industry) |
| Locations | 14 sites (Fullerton, California and 13 other locations) |
| Trial ID | NCT05103683 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, and antitumor activity of a new treatment called TORL-1-23 in patients with advanced solid tumors, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC). Participants must have measurable disease and adequate organ function, and they will be monitored for any adverse effects and treatment efficacy. The study aims to gather crucial data on how this new therapy performs in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with advanced solid tumors who have measurable disease and meet specific health criteria.
Not a fit: Patients with uncontrolled medical conditions, recent cancer treatments, or certain histories of cancer 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 cancers that currently have limited treatment options.
How similar studies have performed: While this is a first-in-human study, similar approaches targeting claudin proteins have shown promise in other studies, indicating potential for success.
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-1-23 * 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 13 other locations
- Providence Medical Foundation — Fullerton, California, United States (RECRUITING)
- UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (RECRUITING)
- University of Kentucky Medical Center — Lexington, Kentucky, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Sarah Cannon Research Institute Texas Oncology — Tyler, Texas, United States (RECRUITING)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (RECRUITING)
- St. Vincent's Hospital, The Catholic University of Korea — Suwon, Gyeonggi-do, South Korea (RECRUITING)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- Severance Hospital — Seoul, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Nora Ku, MD
- Email: nora.ku@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.
Conditions: Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, NSCLC, claudin6