Recruiting

Safety and Antitumor Activity of TORL-1-23 in Advanced Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and antitumor activity of TORL-1-23 in individuals with advanced cancer, by observing the incidence and severity of adverse events and determining the maximum tolerated dose and the recommended phase 2 dose.

What is being tested

TORL-1-23

Drug
Who is being recruted

Urogenital Diseases+15

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorTORL Biotherapeutics, LLC
Study ContactNora Ku, MDMore contacts
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 17, 2021

Actual date on which the first participant was enrolled.

This study is about testing a new drug called TORL-1-23 in people with advanced cancer. The main goal is to see if the drug is safe, well-tolerated, and has potential to fight tumors. It's important because it could lead to a new treatment option for those facing advanced stages of cancer, who often have limited treatment choices. During this study, participants will receive TORL-1-23, and the researchers will monitor their health closely. They'll record any side effects or serious adverse events to understand the safety profile of the drug. They'll also determine the maximum tolerated dose, which is the highest dose that causes harmful effects in less than 33% of participants. This information will help establish a recommended dose for future studies.

Official TitleA Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
NCT05103683
Principal SponsorTORL Biotherapeutics, LLC
Study ContactNora Ku, MDMore contacts
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Advanced solid tumor
Measurable disease, per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
TORL-1-23

Group II

Experimental
TORL-1-23

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Recruiting

Asan Medical Center

Seoul, South KoreaOpen Asan Medical Center in Google Maps
Recruiting

Samsung Medical Center

Seoul, South Korea
Recruiting

Providence Medical Foundation

Fullerton, United States
Recruiting

UCLA - JCCC Clinical Research Unit

Los Angeles, United States
Recruiting
14 Study Centers