Recruiting
Phase 1

UCT-03-008

Sponsor:

1200 Pharma, LLC

Code:

NCT05103046

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UCT-03-008

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumor

Study ID

NCT05103046

Start date

Dec 23, 2021

Status verified date

Mar, 2024

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Finding as Monotherapy - Part 1

UCT-03-008 Dose Finding

experimental: Expansion as Monotherapy - Part 2

UCT-03-008 RP2D Expansion

Interventions

UCT-03-008

Orally available kinase inhibitor

Primary outcome measure

  • Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Alex Garcia

213-5197493AGarcia@trio-us.org

Locations

UCLA - JCCC Clinical Research Unit

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jonathan Goldman, MD

310-923-8712

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

Minal Barve, MD

972-566-3000

More Information

Sponsor

1200 Pharma, LLC

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 1200 Pharma, LLC on 2024-03-12.