Recruiting
Phase 1

TORL-1-23

Sponsor:

TORL Biotherapeutics, LLC

Code:

NCT05103683

Conditions

Advanced Solid Tumor

Ovarian Cancer

Endometrial Cancer

NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TORL-1-23

Study Details

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

Advanced Solid Tumor

Ovarian Cancer

Endometrial Cancer

NSCLC

Study ID

NCT05103683

Start date

Nov 17, 2021

Status verified date

Jul, 2025

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Finding - Part 1

TORL-1-23

experimental: Expansion as Monotherapy - Part 2

TORL-1-23

Interventions

TORL-1-23

antibody drug conjugate (ADC)

Primary outcome measure

  • Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Nora Ku, MD

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

Ibrahim Qazi

310-348-9636

Locations

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

UCLA - JCCC Clinical Research Unit

Recruiting

Los Angeles, California, United States, 90095

Contacts

Gottfried Konecny, MD

310-794-4955

Principal Investigator:

Gottfired Konecny, MD

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Boris Winterhoff, MD, PhD

612-624-8003

Principal Investigator:

Boris Winterhoff, MD, PhD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Andrea Wahner Hendrickson, MD

855-776-0015

Principal Investigator:

Andrea Wahner Hendrickson, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Sarah Cannon Research Institute Texas Oncology

Recruiting

Tyler, Texas, United States, 75702

Principal Investigator:

Heather Pulaski, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

TORL Biotherapeutics, LLC

Last update posted

Feb 13, 2026

Last verified

Jul, 2025

Keywords

  • claudin6

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TORL Biotherapeutics, LLC on 2026-02-13.