NCT06005740PHASE1Recruiting
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
TORL Biotherapeutics, LLC
Start Date
12/4/2023
Completion Date
10/31/2026
Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
Exclusion Criteria:
* 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-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
Interventions
DRUG
TORL-4-500
Conditions
Advanced Solid TumorHepatocellular Carcinoma
Locations
Mayo Clinic Phoenix
Phoenix, Arizona 85054
United States
Providence Medical Foundation
Fullerton, California 92835
United States
UCLA - JCCC Clinical Research Unit
Los Angeles, California 90095
United States
Torrance Memorial Physician Network
Torrance, California 90505
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida 32827
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Virginia Cancer Specialists
Lexington, Virginia 22031
United States
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada