Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05103683

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Led by TORL Biotherapeutics, LLC · Updated on 2026-02-13

90

Participants Needed

14

Research Sites

260 weeks

Total Duration

On this page

Sponsors

T

TORL Biotherapeutics, LLC

Lead Sponsor

T

Translational Research in Oncology

Collaborating Sponsor

AI-Summary

What this Trial Is About

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

CONDITIONS

Official Title

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced solid tumor
  • Measurable disease, per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Not recovered from acute toxicities of previous therapy except alopecia or certain lab abnormalities
  • Received prior cancer treatments within 14 days (small molecule) or 28 days (biologic) before 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 or acute myeloid leukemia
  • History of another cancer within 3 years before study treatment, except certain treated skin cancers and low-risk malignancies
  • Pregnant or breastfeeding if female

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Providence Medical Foundation

Fullerton, California, United States, 92835

Actively Recruiting

2

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States, 90095

Actively Recruiting

3

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

4

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

5

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

8

Sarah Cannon Research Institute Texas Oncology

Tyler, Texas, United States, 75702

Actively Recruiting

9

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

10

St. Vincent's Hospital, The Catholic University of Korea

Suwon, Gyeonggi-do, South Korea, 16247

Actively Recruiting

11

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

12

Severance Hospital

Seoul, South Korea, 03723

Actively Recruiting

13

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

14

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

N

Nora Ku, MD

CONTACT

I

Ibrahim Qazi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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First in Human Study of TORL-1-23 in Participants With Advanced Cancer | DecenTrialz