This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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-1-23
* 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 (14)
Facility
City
Region
Status
Providence Medical Foundation
Fullerton
California
Recruiting
UCLA - JCCC Clinical Research Unit
Los Angeles
California
Recruiting
University of Kentucky Medical Center
Lexington
Kentucky
Recruiting
University of Minnesota
Minneapolis
Minnesota
Recruiting
Mayo Clinic in Rochester
Rochester
Minnesota
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Sarah Cannon Research Institute Texas Oncology
Tyler
Texas
Recruiting
Virginia Cancer Specialists
Fairfax
Virginia
Recruiting
St. Vincent's Hospital, The Catholic University of Korea
Suwon
Gyeonggi-do
Recruiting
Seoul National University Hospital
Seoul
South Korea
Recruiting
Severance Hospital
Seoul
South Korea
Recruiting
Asan Medical Center
Seoul
South Korea
Recruiting
Samsung Medical Center
Seoul
South Korea
Recruiting
Official registry record
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.