First in Human Study of TORL-1-23 in Participants With Advanced Cancer
NCT ID: NCT05103683
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2021-11-17
2026-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Finding - Part 1
TORL-1-23
TORL-1-23
antibody drug conjugate (ADC)
Expansion as Monotherapy - Part 2
TORL-1-23
TORL-1-23
antibody drug conjugate (ADC)
Interventions
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TORL-1-23
antibody drug conjugate (ADC)
Eligibility Criteria
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Inclusion Criteria
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Translational Research in Oncology
OTHER
TORL Biotherapeutics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Hatem Dokainish
Role: STUDY_CHAIR
TORL Biotherapeutics, LLC
Locations
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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
Countries
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Central Contacts
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Ibrahim Qazi
Role: CONTACT
Facility Contacts
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Yung Lyou, MD
Role: primary
Gottfried Konecny, MD
Role: primary
John Villano, MD
Role: primary
Boris Winterhoff, MD, PhD
Role: primary
Andrea Wahner Hendrickson, MD
Role: primary
Emily Slotkin, MD
Role: primary
Alex Adjei, MD
Role: primary
Heather Pulaski, MD
Role: primary
Alexander Spira, MD
Role: primary
Byoung Yong Shim, MD
Role: primary
Bhumsuk Keam, MD
Role: primary
Gun Min Kim, MD
Role: primary
Shinkyo Yoon, MD
Role: primary
Jinseok Ahn, MD
Role: primary
Other Identifiers
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TORL123-001
Identifier Type: -
Identifier Source: org_study_id
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