CP-383 for 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
This trial tests whether the oral drug CP-383 can slow or stop growth in adults with advanced or metastatic solid tumors who have exhausted standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tasca Therapeutics Industry-sponsored |
| Locations | 13 sites (Denver, Colorado and 12 other locations) |
| Trial ID | NCT07030257 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2, first-in-human program using dose escalation to identify a safe and active daily oral dose of CP-383, followed by dose-expansion cohorts in selected tumor types and mutation-defined groups. Participants will take CP-383 daily until disease progression or unacceptable side effects, with weekly clinic visits for the first six weeks and visits every three weeks thereafter for safety and response monitoring. Tumor tissue or a fresh biopsy and genomic testing will be required to explore whether specific gene mutations (including FAT1 loss-of-function) predict response. The trial enrolls a variety of advanced solid tumors (excluding primary brain cancers) and includes focused cohorts such as colorectal, small cell lung, head and neck, pancreatic, bladder, and non-small cell lung cancers.
Who should consider this trial
Good fit: Adults with locally advanced, recurrent, or metastatic solid tumors (excluding primary brain cancers) that have progressed after or are not eligible for standard treatments, who can provide tumor tissue or undergo a safe biopsy, are the intended candidates.
Not a fit: Patients who still have effective standard therapy available, who cannot take an oral investigational drug, or who have uncontrolled brain metastases or other exclusionary conditions may not benefit or be eligible.
Why it matters
Potential benefit: If successful, CP-383 could shrink tumors or delay progression and offer a new treatment option for patients whose cancers no longer respond to standard therapies.
How similar studies have performed: CP-383 is an early-stage investigational agent with limited human data; while other targeted drugs have helped mutation-defined cancers, CP-383 itself remains largely untested in patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Measurable or non measurable cancer that the research can assess for changes * Not eligible or able to take existing standard therapies for cancer * Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor * Diagnosed with locally advanced, recurrent or metastatic incurable disease * Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment * Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer * Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer * Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer \_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer * Adequate blood and urine lab tests * Women and men of childbearing potential with adequate contraception * Provides written informed consent * Willing to comply with the requirements of the protocol Exclusion Criteria: * Inability to swallow pills * Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load * Active tumor in the brain * Clinically significant liver disease * Significant gastrointestinal diseases * History of other cancer within past 5 years with certain exceptions for cancers that are likely cured * Significant cardiac disease * Other diseases that are not well controlled that could make taking the drug unsafe * pregnant or lactating females * Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug
Where this trial is running
Denver, Colorado and 12 other locations
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (Recruiting)
- Florida Cancer Specialists-Lake Nona — Orlando, Florida, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
- Carolina BioOncology Institute — Huntersville, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Taylor Cancer Research Center — Maumee, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- NEXT Oncology - Dallas — Dallas, Texas, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Tasca Therapeutics
- Email: trials@tascatx.com
- Phone: 617-430-7109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.