Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
St. Vincent's Hospital, The Catholic University of Korea.
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Virginia Cancer Specialists
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Providence Medical Foundation
Coordinator of this site? Confirm its status
FullertonUnited StatesRecruiting
University of Kentucky Medical Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
UCLA - JCCC Clinical Research Unit
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Sarah Cannon Research Institute Texas Oncology
Coordinator of this site? Confirm its status
TylerUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.