RecruitingPhase 1NCT05103683

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

A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer


Sponsor

TORL Biotherapeutics, LLC

Enrollment

90 participants

Start Date

Nov 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria8

  • 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

Interventions

DRUGTORL-1-23

antibody drug conjugate (ADC)


Locations(14)

Providence Medical Foundation

Fullerton, California, United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Sarah Cannon Research Institute Texas Oncology

Tyler, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

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

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05103683


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