First in Human Study of TORL-1-23 in Participants With Advanced Cancer

• Status: Not yet recruiting
• Trial end date: 2025-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TORL Biotherapeutics, LLC
• Collaborator: Translational Research in Oncology

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-1-23

• 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