First in Human Study of TORL-3-600 in Participants With Advanced Cancer

Launched by TORL BIOTHERAPEUTICS, LLC · Jul 9, 2023

Keywords

ClinConnect Summary

This clinical trial, called the "First in Human Study of TORL-3-600," is exploring a new treatment for patients with advanced solid tumors, including colorectal cancer. The main goals of the study are to find out if TORL-3-600 is safe for people to use, how well it works against cancer, and how the body processes the drug. The trial is currently looking for participants aged 65 and older who have measurable cancer that has not responded to other treatments. To be eligible, patients should have a good level of physical activity (ECOG performance status 0-1) and healthy organ function.

Participants in this trial will receive the TORL-3-600 treatment and will be closely monitored for any side effects and how their cancer responds to the drug. This is a first step in testing the drug in humans, so the information gathered will help researchers understand its safety and effectiveness. It’s important to note that there are certain health conditions that may exclude someone from participating, such as having untreated infections or recent serious heart problems. Overall, this study represents an exciting opportunity for patients seeking new treatment options for 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-3-600
• • 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