A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Purpose
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).
Conditions
- Advanced Solid Tumor
- Hepatocellular Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Monotherapy Dose Dose Finding - Part 1 |
TORL-4-500 iv once every 3 weeks |
|
|
Experimental Expansion as Monotherapy - Part 2 |
TORL-4-500 iv once every 3 weeks |
|
Recruiting Locations
Mayo Clinic Phoenix
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Mohamad Sonbol, MD
Mohamad Sonbol, MD
Providence Medical Foundation
Fullerton, California 92835
Fullerton, California 92835
Contact:
Yung Lyou, MD
Yung Lyou, MD
UCLA - JCCC Clinical Research Unit
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Lee Rosen, MD
310-829-5471
Lee Rosen, MD
310-829-5471
Torrance Memorial Physician Network
Torrance, California 90505
Torrance, California 90505
Contact:
Justin Tiulim, MD
Justin Tiulim, MD
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
Yanyan Lou, MD
Yanyan Lou, MD
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida 32827
Orlando, Florida 32827
Contact:
Cesar Perez, MD
Cesar Perez, MD
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Andrea Wahner-Hendrickson, MD
Andrea Wahner-Hendrickson, MD
Virginia Cancer Specialists
Lexington, Virginia 22031
Lexington, Virginia 22031
Contact:
Alexander Spira, MD
Alexander Spira, MD
More Details
- Status
- Recruiting
- Sponsor
- TORL Biotherapeutics, LLC