Clinical trial Recruiting at 14 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorTORL Biotherapeutics, LLC
Industry-sponsored
Locations14 sites (Fullerton, California and 13 other locations)
StatusRecruiting
StartedNovember 17, 2021
Main results expectedAugust 31, 2026
Study endsNovember 15, 2026
Registry record updatedFebruary 13, 2026
Trial IDNCT05103683 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Evaluating PC14586 for advanced solid tumors with a specific mutation

    This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.

    Recruiting at 71 sites Phase 1/2 PMV Pharmaceuticals, Inc · Irvine, California and 75 other locations · NCT04585750

  • NRM-823 for advanced or metastatic refractory solid tumors

    This trial tests whether NRM-823 is safe and can help people with advanced or metastatic head and neck, esophageal, gastric, or related cancers.

    Recruiting at 18 sites Phase 1 Normunity AccelCo, Inc. · Denver, Colorado and 17 other locations · NCT07182149

  • 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.

    Recruiting at 12 sites Phase 1 MacroGenics · Los Angeles, California and 11 other locations · NCT06242470

  • 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.

    Recruiting Centro di Riferimento Oncologico - Aviano · Aviano, Pordonone · NCT06028724

  • 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

    Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

  • 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.

    Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.