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

NCT05103683 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TORL123-001
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 14

Brief Summary

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

Conditions

Ovarian Cancer; Endometrial Cancer; NSCLC; Advanced Solid Tumor

Keywords

claudin6

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events and serious adverse events

  Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

  up to 2 years

• Maximum Tolerated Dose (MTD)

  Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

  28 Days

• Recommended Phase 2 Dose (RP2D)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  up to 2 years

Secondary Outcomes (20)

• Objective Response Rate (ORR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Progression Free Survival (PFS)

  up to 2 years

• Time to Response (TTR)

  up to 2 years

• 1 Year Overall Survival (1YOS)

  1 year

Study Arms (2)

Monotherapy Dose Finding - Part 1

EXPERIMENTAL

TORL-1-23

Drug: TORL-1-23

Expansion as Monotherapy - Part 2

EXPERIMENTAL

TORL-1-23

Drug: TORL-1-23

Interventions

TORL-1-23 DRUG

antibody drug conjugate (ADC)

Expansion as Monotherapy - Part 2; Monotherapy Dose Finding - Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

You may not qualify if:

• 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
• 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
• If female, is pregnant or breastfeeding

Sponsors & Collaborators

• TORL Biotherapeutics, LLC: lead
• Translational Research in Oncology: collaborator

Study Sites (14)

Providence Medical Foundation

Fullerton, California, 92835, United States

RECRUITING

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Sarah Cannon Research Institute Texas Oncology

Tyler, Texas, 75702, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

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

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03723, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Nora Ku, MD

  TORL Biotherapeutics, LLC

  STUDY CHAIR

Central Study Contacts

Nora Ku, MD

CONTACT

310-348-9636; nora.ku@torlbio.com

Ibrahim Qazi

CONTACT

310-348-9636

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: November 17, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5); US (9)