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

Last updated: February 17, 2026
Sponsor: Tasca Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Non-small Cell Lung Cancer

Digestive System Neoplasms

Treatment

CP-383

Clinical Study ID

NCT07030257
TAS-CP383-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 safebiopsy 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 forwhom a clinical trial is an option for continued treatment

  • Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectalcancer, 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 mutationin the cancer

  • Part 1: selected solid tumor cancer types (with the exception of brain cancers) thathave a specific gene mutation in the cancer

  • Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectalcancer, small cell lung cancer, head and neck cancer - some of these will have aspecific 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

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 thatare 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 thestart of study drug

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: CP-383
Phase: 1/2
Study Start date:
August 27, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Sarah Cannon Research Institute at HealthONE

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists-Lake Nona

    Orlando 4167147, Florida 4155751 32827
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Active - Recruiting

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Taylor Cancer Research Center

    Maumee 5162137, Ohio 5165418 43537
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • NEXT Oncology - Dallas

    Dallas 4684888, Texas 4736286 75039
    United States

    Active - Recruiting

  • START San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City 5784607, Utah 5549030 84119
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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