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

NCT07030257 · Tasca Therapeutics
In plain English

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Official title
A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
About this study
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
Eligibility 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
Study design
Enrollment target: 150 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-27
Estimated completion: 2029-02
Last updated: 2026-02-18
Interventions
Drug: CP-383
Primary outcomes
  • Part 1: Determine the maximum tolerated dose (MTD) (21 days)
  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types (From enrollment through study completion, an average of 1 year)
Sponsor
Tasca Therapeutics · industry
Contacts & investigators
ContactTasca Therapeutics · contact · trials@tascatx.com · 617-430-7109
All locations (13)
Sarah Cannon Research Institute at HealthONERecruiting
Denver, Colorado, United States
Florida Cancer Specialists-Lake NonaRecruiting
Orlando, Florida, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Carolina BioOncology InstituteRecruiting
Huntersville, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Taylor Cancer Research CenterRecruiting
Maumee, Ohio, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
NEXT Oncology - DallasRecruiting
Dallas, Texas, United States
START San AntonioRecruiting
San Antonio, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors · TrialPath