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Back|NCT05103046Recruiting
Official Title

A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors

Phase
Phase 1
Sponsor
1200 Pharma, LLC
Enrollment
68
Timeline
Dec 2021 → Dec 2025
About This Study

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  • 1Advanced solid tumor
  • 2Measurable disease, per RECIST v1.1
  • 3Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 4Adequate organ function

Exclusion Criteria

  • 1Has 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
  • 2Received 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
  • 3Progressive or symptomatic brain metastases
  • 4Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • 5History of significant cardiac disease
  • 6History or current evidence/risk of retinopathy
  • 7History of myelodysplastic syndrome (MDS) or AML
  • 8History 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
  • 9If female, is pregnant or breastfeeding

Locations

5 sites participating in this study

Winship Institute of Emory University

Atlanta, Georgia 30322

Terminated

UCLA - JCCC Clinical Research Unit

Los Angeles, California 90095

Recruiting

Jonathan Goldman, MD

310-923-8712

Torrance Memorial

Torrance, California 90505

Terminated
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →