NCT05103683RecruitingPhase 1
First in Human Study of TORL-1-23 in Participants With Advanced Cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 21 Oct 2021
- Start date
- 17 Nov 2021
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- TORL Biotherapeutics, LLC
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT05103683
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 17 Nov 2021 to the primary completion date, 31 Aug 2026
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- Progressive or symptomatic brain metastases
- If female, is pregnant or breastfeeding
Who the study is looking for
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| St. Vincent's Hospital, The Catholic University of Korea. Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
| University of Kentucky Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| UCLA - JCCC Clinical Research Unit Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Sarah Cannon Research Institute Texas Oncology Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.