TORL-4-500 for Advanced Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires that you have not received any chemotherapeutic, investigational, or other therapies for cancer within 14 days for small molecule drugs and 28 days for biologic drugs before starting the trial. It does not specify other medications, so you may need to discuss with the trial team.
What data supports the effectiveness of the drug TORL-4-500 for advanced cancer?
What safety data exists for TORL-4-500 or similar treatments in humans?
The safety profiles of drugs for advanced melanoma, including targeted therapies, show common side effects like skin issues and endocrine disorders. Serious adverse effects can occur with cancer therapies, sometimes requiring intensive care. It's important to have healthcare professionals manage these complications.678910
What makes the drug TORL-4-500 unique for advanced cancer treatment?
The drug TORL-4-500 is unique because it may offer a novel approach to treating advanced cancer by potentially targeting specific pathways or mechanisms that are not addressed by current standard treatments, such as CDK 4/6 inhibitors or m-TOR inhibitors, which are commonly used in hormone receptor-positive, HER2-negative breast cancer. This could provide new options for patients who have developed resistance to existing therapies.1112131415
What is the purpose of this trial?
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
Research Team
Caroline Labib, PharmD
Principal Investigator
TORL Biotherapeutics, LLC
Eligibility Criteria
This trial is for adults with advanced solid tumors, including liver cancer, who have measurable disease and are in good physical condition (ECOG 0-1). They must have proper organ function and not be recovering from severe side effects of previous treatments. People with brain metastases, significant heart issues, recent cancer therapies, uncontrolled diseases or infections, a history of certain blood disorders or another cancer within the last three years cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Part 1
Monotherapy Dose Finding with TORL-4-500 administered intravenously once every 3 weeks
Treatment - Part 2
Expansion as Monotherapy with TORL-4-500 administered intravenously once every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TORL-4-500
Find a Clinic Near You
Who Is Running the Clinical Trial?
TORL Biotherapeutics, LLC
Lead Sponsor
Translational Research in Oncology
Collaborator