NCT07030257

Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tasca Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are: * Does CP-383 slow or stop the growth of cancer in patients with advanced cancer * What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383 Participants will: * Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth * Visit the clinic weekly for the first 6 weeks for checkups and tests * Visit the clinic every 3 weeks thereafter for checkups and tests

Conditions

• Solid Tumor Malignancies
• Colorectal Carcinoma
• Small Cell Lung Cancer ( SCLC )
• Head and Neck (HNSCC)
• Bladder Cancer
• Non-Small Cell Lung Cancer
• Pancreatic Cancer, Advanced or Metastatic

Interventions

Type	Name	Description
DRUG	CP-383	Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Timeline

• Start date: 2025-08-27
• Primary completion: 2028-08-15
• Completion: 2029-02-01
• First posted: 2025-06-22
• Last updated: 2026-02-18

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study