A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
NCT ID: NCT06005740
Last Updated: 2025-03-04
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
70 participants
INTERVENTIONAL
2023-12-04
2026-10-31
Brief Summary
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For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
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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-4-500 iv once every 3 weeks
TORL-4-500
antibody drug conjugate
Expansion as Monotherapy - Part 2
TORL-4-500 iv once every 3 weeks
TORL-4-500
antibody drug conjugate
Interventions
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TORL-4-500
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-4-500
* 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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Caroline Labib, PharmD
Role: STUDY_CHAIR
TORL Biotherapeutics, LLC
Locations
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Mayo Clinic Phoenix
Phoenix, Arizona, United States
Providence Medical Foundation
Fullerton, California, United States
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States
Torrance Memorial Physician Network
Torrance, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Virginia Cancer Specialists
Lexington, Virginia, United States
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Mohamad Sonbol, MD
Role: primary
Yung Lyou, MD
Role: primary
Lee Rosen, MD
Role: primary
Justin Tiulim, MD
Role: primary
Yanyan Lou, MD
Role: primary
Cesar Perez, MD
Role: primary
Andrea Wahner-Hendrickson, MD
Role: primary
Alexander Spira, MD
Role: primary
Erica Tsang
Role: primary
Ramy Saleh, MD
Role: primary
Other Identifiers
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TORL4500-001
Identifier Type: -
Identifier Source: org_study_id
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