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NCT Number: NCT07030257

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

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

Recruiting

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Key information

Conditions

Solid Tumor Malignancies Bladder Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck (HNSCC) Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Non-small Cell Lung Cancer Pancreatic Cancer, Advanced or Metastatic Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer ( SCLC ) Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-383

Drug

Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Primary outcomes

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

    Time frame: 21 days

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

  2. 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

    Objective response rate assessed by the investigator according to RECIST

Secondary outcomes

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

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

    Assess standard PK parameters including Cmax

  2. Part 1: Determine the pharmacokinetics parameters of CP-383

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

    Assess standard PK parameters including tmax

  3. Part 1: Determine the pharmacokinetics parameters of CP-383

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

    Assess standard PK parameters including AUC

  4. 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

    Incidence and severity of Adverse events and changes in test results

  5. 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

    Incidence of AEs and changes in test results

  6. 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

    Evaluate duration of response

  7. 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

    Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months

  8. 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

    Evaluate progression free survival

  9. 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

    Evaluate overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Tasca Therapeutics

CONTACT

[email protected]

617-430-7109

Sponsors and collaborators

Lead sponsor

Tasca Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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