First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
NCT ID: NCT05103046
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
68 participants
INTERVENTIONAL
2021-12-23
2025-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Finding as Monotherapy - Part 1
UCT-03-008 Dose Finding
UCT-03-008
Orally available kinase inhibitor
Expansion as Monotherapy - Part 2
UCT-03-008 RP2D Expansion
UCT-03-008
Orally available kinase inhibitor
Interventions
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UCT-03-008
Orally available kinase inhibitor
Eligibility Criteria
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Inclusion Criteria
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
Exclusion Criteria
* 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-03-008
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* 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
18 Years
ALL
No
Sponsors
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Translational Research in Oncology
OTHER
1200 Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Alex Garcia
Role: STUDY_DIRECTOR
TRIO-US
Locations
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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
Mary Crowley Cancer Research
Dallas, Texas, United States
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan Goldman, MD
Role: primary
Minal Barve, MD
Role: primary
Other Identifiers
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UCT03008-001
Identifier Type: -
Identifier Source: org_study_id
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