First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.

Key facts

Study ID

NCT04761601

Run by

1200 Pharma, LLC

People needed

32

Starts

2021-03-03

Expected to finish

2024-02-29

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

You may not qualify if…

• 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

Where it is running

• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States
• Torrance Memorial — Torrance, California, United States
• Winship Institute of Emory University — Atlanta, Georgia, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Sarah Cannon — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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