Overview
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
Eligibility
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-2-307-ADC
- 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