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

Last updated: February 27, 2025
Sponsor: TORL Biotherapeutics, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Ovarian Cancer

Non-small Cell Lung Cancer

Pelvic Cancer

Treatment

TORL-1-23

Clinical Study ID

NCT05103683
TORL123-001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Advanced solid tumor

  • Measurable disease, per RECIST v1.1

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from theacute toxicities of previous therapy, except treatment-related alopecia orlaboratory abnormalities otherwise meeting eligibility requirements

  • Received prior chemotherapeutic, investigational, or other therapies for thetreatment of cancer within 14 days with small molecule and within 28 days withbiologic 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 theexception of basal or squamous cell carcinoma of the skin that has been definitivelytreated. A history of other malignancies with a low risk of recurrence, includingappropriately treated ductal carcinoma in situ (DCIS) of the breast and prostatecancer with a Gleason score less than or equal to 6, are also not excluded

  • If female, is pregnant or breastfeeding

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: TORL-1-23
Phase: 1
Study Start date:
November 17, 2021
Estimated Completion Date:
November 15, 2025

Connect with a study center

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

    Suwon-si, Gyeonggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03723
    Korea, Republic of

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Active - Recruiting

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute Texas Oncology

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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