A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Launched by TORL BIOTHERAPEUTICS, LLC · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TORL-4-500 in patients with advanced cancer, particularly those with solid tumors like liver cancer. The main goals of the study are to see how safe the treatment is, how well it works, and how the body processes it. This is an early-stage trial, which means it's the first time this treatment is being tested in people.

To participate, patients should have an advanced solid tumor that can be measured, good overall health, and specific organ functions. They should not have had certain cancer treatments recently, nor should they have serious uncontrolled health issues. Participants will receive the treatment and will be closely monitored for any side effects and how their cancer responds. This study is currently recruiting patients aged 65 to 74, and it welcomes individuals of any gender. If you or someone you know is interested in this trial, it’s a chance to help researchers learn more about a potential new option for treating advanced cancer.

Gender

ALL

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