Testing UCT-03-008 in patients with advanced solid tumors

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

This study is testing a new treatment called UCT-03-008 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 1200 Pharma, LLC (Industry-sponsored)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT05103046 on ClinicalTrials.gov

What this trial studies

This first-in-human study aims to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of a new treatment called UCT-03-008 in patients diagnosed with advanced solid tumors. Participants will be monitored for their response to the treatment and any potential side effects. The study will include patients with measurable disease and adequate organ function, ensuring a thorough assessment of the drug's effects. This phase 1 trial is crucial for determining the initial safety profile of UCT-03-008.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with advanced solid tumors who have measurable disease and an ECOG performance status of 0-1.

Not a fit: Patients with uncontrolled medical conditions, significant cardiac disease, or those who have received recent cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in evaluating new cancer therapies.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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-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

Where this trial is running

Los Angeles, California and 4 other locations

• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (Recruiting)
• Torrance Memorial — Torrance, California, United States (Terminated)
• Winship Institute of Emory University — Atlanta, Georgia, United States (Terminated)
• Mary Crowley Cancer Research — Dallas, Texas, United States (Recruiting)
• START (South Texas Accelerated Research Therapeutics) — San Antonio, Texas, United States (Terminated)

Study contacts

• Study coordinator: Alex Garcia

Conditions Advanced Solid Tumor