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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

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

ArmDescriptionAssigned Intervention
Experimental
Monotherapy Dose Dose Finding - Part 1 		TORL-4-500 iv once every 3 weeks
  • Drug: TORL-4-500
    antibody drug conjugate
Experimental
Expansion as Monotherapy - Part 2 		TORL-4-500 iv once every 3 weeks
  • Drug: TORL-4-500
    antibody drug conjugate

Recruiting Locations

Mayo Clinic Phoenix
Phoenix, Arizona 85054
Contact:
Mohamad Sonbol, MD

Providence Medical Foundation
Fullerton, California 92835
Contact:
Yung Lyou, MD

UCLA - JCCC Clinical Research Unit
Los Angeles, California 90095
Contact:
Lee Rosen, MD
310-829-5471

Torrance Memorial Physician Network
Torrance, California 90505
Contact:
Justin Tiulim, MD

Mayo Clinic Jacksonville
Jacksonville, Florida 32224
Contact:
Yanyan Lou, MD

Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida 32827
Contact:
Cesar Perez, MD

Mayo Clinic Rochester
Rochester, Minnesota 55905
Contact:
Andrea Wahner-Hendrickson, MD

Virginia Cancer Specialists
Lexington, Virginia 22031
Contact:
Alexander Spira, MD

More Details

Status
Recruiting
Sponsor
TORL Biotherapeutics, LLC

Study Contact

Caroline Labib, PharmD
310-348-9636
caroline.labib@torlbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.