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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07030257Sponsor: Tasca TherapeuticsLast updated: 2026-02-18

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

Arms & interventions

  • DrugCP-383

    Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Outcome measures

Primary

  • Part 1: Determine the maximum tolerated dose (MTD)

    Determine the MTD of CP-383 in subjects with advanced solid tumors

    Time frame: 21 days

  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

    Objective response rate assessed by the investigator according to RECIST

    Time frame: From enrollment through study completion, an average of 1 year

Secondary

  • Part 1: Determine the pharmacokinetics parameters of CP-383

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 1: Determine the pharmacokinetics parameters of CP-383

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 1: Determine the pharmacokinetics parameters of CP-383

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

    Time frame: From enrollment through study completion, an average of 1 year

  • Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

    Time frame: From enrollment through study completion, an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (13)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

Recruiting
Gerald Falchook, MD · Principal Investigator

Florida Cancer Specialists-Lake Nona

Orlando, Florida, 32827

Recruiting
Elizabeth Gilmore · Contact
Cesar Perez, MD · Principal Investigator

START Midwest

Grand Rapids, Michigan, 49546

Recruiting
Sreenivasa Chandana, MD · Principal Investigator

Washington University

St Louis, Missouri, 63110

Recruiting
Sara Mitchum · Contact
Nikolaos Trikalinos, MD · Principal Investigator

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting
Ralph Hauke, MD · Principal Investigator

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

Recruiting
Neel Gandhi, MD · Principal Investigator

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Taussig Research · Contact
Alex Adjei, MD · Principal Investigator

Taylor Cancer Research Center

Maumee, Ohio, 43537

Recruiting
Stephanie Ambrose, RN, BSN, CCRC · Contact

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Roger Cohen, MD · Principal Investigator

NEXT Oncology - Dallas

Dallas, Texas, 75039

Recruiting
Mofopefoluwa Akinwale · Contact
Michael Song, MD, PhD, PharmD · Principal Investigator

START San Antonio

San Antonio, Texas, 78229

Recruiting
Kyriakos P. Papadopoulos, MD · Principal Investigator

START Mountain Region

West Valley City, Utah, 84119

Recruiting
William McKean, MD, PhD · Principal Investigator

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting
Maybelle De La Rosa · Contact
Alexander Spira, MD · Principal Investigator