Status:
TERMINATED
First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
Lead Sponsor:
1200 Pharma, LLC
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.
Eligibility Criteria
Inclusion
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Exclusion
- 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 UCT-01-097
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- History of phosphate or calcium disorder
- History of significant cardiac disease
- History or current evidence/risk of retinopathy
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04761601
Start Date
March 3 2021
End Date
February 29 2024
Last Update
March 13 2024
Active Locations (6)
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1
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States, 90095
2
Torrance Memorial
Torrance, California, United States, 90505
3
Winship Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804