First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
NCT ID: NCT05156866
Last Updated: 2026-01-13
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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ACTIVE_NOT_RECRUITING
PHASE1
163 participants
INTERVENTIONAL
2022-02-02
2027-02-15
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 Dose Finding - Part 1
TORL-2-307-ADC
TORL-2-307-ADC
antibody drug conjugate
Expansion as Monotherapy - Part 2
TORL-2-307-ADC
TORL-2-307-ADC
antibody drug conjugate
Interventions
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TORL-2-307-ADC
antibody drug conjugate
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-2-307-ADC
* 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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Ibrahim Qazi, PharmD
Role: STUDY_CHAIR
TORL Biotherapeutics, LLC
Locations
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Providence St. Jude Medical Center
Fullerton, California, United States
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States
Torrance Memorial Medical
Torrance, California, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Washington University School of Medicine-Siteman Cancer Center
St Louis, Missouri, United States
Texas Oncology-Austin
Austin, Texas, United States
Texas Oncology-Dallas
Dallas, Texas, United States
START San Antonio
San Antonio, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
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References
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O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353.
Other Identifiers
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TORL2307ADC-001
Identifier Type: -
Identifier Source: org_study_id
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