First in Human Study of TORL-4-500 in Participants With Advanced Cancer
Advanced Solid Tumor, Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Advanced Solid Tumor focused on measuring ADC
Eligibility Criteria
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
Sites / Locations
- UCLA - JCCC Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Monotherapy Dose Dose Finding - Part 1
Expansion as Monotherapy - Part 2
TORL-4-500 iv once every 3 weeks
TORL-4-500 iv once every 3 weeks