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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Incidence and severity of adverse events and serious adverse events — up to 2 years Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Maximum Tolerated Dose (MTD) — 28 Days Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D) — up to 2 years Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Trial sites (10)
Facility
City
Region
Status
Mayo Clinic Phoenix
Phoenix
Arizona
Recruiting
Providence Medical Foundation
Fullerton
California
Recruiting
UCLA - JCCC Clinical Research Unit
Los Angeles
California
Recruiting
Torrance Memorial Physician Network
Torrance
California
Recruiting
Mayo Clinic Jacksonville
Jacksonville
Florida
Recruiting
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando
Florida
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Recruiting
Virginia Cancer Specialists
Lexington
Virginia
Recruiting
University Health Network, Princess Margaret Cancer Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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