RECRUITING

First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

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Conditions

Advanced Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-12-23
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05103046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Advanced solid tumor
  2. * Measurable disease, per RECIST v1.1
  3. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. * Adequate organ function
  1. * 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
  2. * 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
  3. * Progressive or symptomatic brain metastases
  4. * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  5. * History of significant cardiac disease
  6. * History or current evidence/risk of retinopathy
  7. * History of myelodysplastic syndrome (MDS) or AML
  8. * 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
  9. * If female, is pregnant or breastfeeding

Contacts and Locations

Study Contact

Alex Garcia
CONTACT
213-5197493
AGarcia@trio-us.org

Principal Investigator

Alex Garcia
STUDY_DIRECTOR
TRIO-US

Study Locations (Sites)

UCLA - JCCC Clinical Research Unit
Los Angeles, California, 90095
United States
Torrance Memorial
Torrance, California, 90505
United States
Winship Institute of Emory University
Atlanta, Georgia, 30322
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: 1200 Pharma, LLC

  • Alex Garcia, STUDY_DIRECTOR, TRIO-US

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-23
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2021-12-23
Study Completion Date2025-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor