Testing TORL-1-23 in patients with advanced cancer
Official title: A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
Run by TORL Biotherapeutics, LLC · NCT05103683 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | TORL Biotherapeutics, LLC Industry-sponsored |
| Locations | 14 sites (Fullerton, California and 13 other locations) |
| Status | Recruiting |
| Started | November 17, 2021 |
| Main results expected | August 31, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT05103683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with advanced solid tumors who have measurable disease and meet specific health criteria.
✕Probably not a fit
Patients with uncontrolled medical conditions, recent cancer treatments, or certain histories of cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this is a first-in-human study, similar approaches targeting claudin proteins have shown promise in other studies, indicating potential for success.
Who can join: the full rules
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 it's running
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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
Show 8 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
NRM-823 for advanced or metastatic refractory solid tumors
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-
Testing MGC026 in patients with advanced solid tumors
This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.
-
Evaluating mutations in solid tumors using liquid biopsy and genome sequencing
This study is trying to see if a blood test can find important gene changes in patients with advanced solid tumors to help doctors choose the best treatments for them.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
-
Methylation markers in self-samples to help detect gynecological cancers
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.