This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC 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-2-307-ADC
* 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 (12)
Facility
City
Region
Status
Providence St. Jude Medical Center
Fullerton
California
UCLA - JCCC Clinical Research Unit
Los Angeles
California
Torrance Memorial Medical
Torrance
California
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Indiana
Washington University School of Medicine-Siteman Cancer Center
St Louis
Missouri
Texas Oncology-Austin
Austin
Texas
Texas Oncology-Dallas
Dallas
Texas
START San Antonio
San Antonio
Texas
Texas Oncology-Tyler
Tyler
Texas
Seoul National University Hospital
Seoul
South Korea
Severance Hospital, Yonsei University Health System
Seoul
South Korea
Seoul National University Bundang Hospital
Seoul
South Korea
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.
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