Tests TORL-1-23 in adults with advanced solid tumors, including ovarian, endometrial and lung cancer
Tests the new drug TORL-1-23 in adults with advanced cancer to study its safety.
Plain-language title generated from the registry record
Registry title: First in Human Study of TORL-1-23 in Participants With Advanced Cancer
Key facts
- Where
- Seoul and Suwon, South KoreaSee the 5 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced solid tumor that can be measured on scans and who are fairly active day to day. It tests the new drug TORL-1-23.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced solid tumor with disease that can be measured per RECIST v1.1. Listed conditions: ovarian cancer, endometrial cancer, NSCLC.
- Earlier treatment
- Cancer treatment within 14 days (small molecule drugs) or 28 days (biologic drugs) before the first dose of TORL-1-23 is not allowed. Side effects of earlier treatment must have settled to grade 1 or less.
Main reasons for not taking part
- Brain metastases that are growing or cause symptoms
- Serious uncontrolled illness or active uncontrolled infection
- History of significant heart disease
- History of myelodysplastic syndrome (MDS) or AML
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in South Korea
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
- St. Vincent's Hospital, The Catholic University of Korea.Suwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TORL Biotherapeutics, LLC
- Trial code
- NCT05103683
- Record updated
- 13 February 2026
- Original description
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancerRead full original descriptionShow less
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
Inclusion: Advanced solid tumor; Measurable disease, per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Adequate organ function.
Exclusion: 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; 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; 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; Progressive or symptomatic brain metastases; If female, is pregnant or breastfeeding.