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Actively Recruiting
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
About
Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
22-000012
Category
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Sarcoma
Stomach Cancer
Principal Investigator
Contact
Location
- TRIO-US - Ft. Wayne IN
- TRIO-US - Fullerton
- TRIO-US - Redondo Beach
- UCLA San Luis Obispo
- UCLA Santa Barbara
- UCLA Santa Monica