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

February 17, 2026 updated by: Tasca Therapeutics

A Multi-Center, Open Label, Phase 1/2 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthOne
        • Principal Investigator:
          • Gerald Falchook, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists-Lake Nona
        • Principal Investigator:
          • Cesar Perez, MD
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Nikolaos Trikalinos, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Ralph Hauke, MD
        • Contact:
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina Biooncology Institute
        • Principal Investigator:
          • Neel Gandhi, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Alex Adjei, MD
        • Contact:
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Roger Cohen, MD
    • Texas
      • Dallas, Texas, United States, 75039
        • Recruiting
        • Next Oncology - Dallas
        • Contact:
        • Principal Investigator:
          • Michael Song, MD, PhD, PharmD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio
        • Contact:
        • Principal Investigator:
          • Kyriakos P. Papadopoulos, MD
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
        • Principal Investigator:
          • William McKean, MD, PhD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Virginia
        • Principal Investigator:
          • Alexander Spira, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
CP-383, single daily oral capsule, 0.8 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Dose Level 2
CP-383, single daily oral capsule, 1.6 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Dose Level 3
CP-383, single daily oral capsule, 3.0 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Dose Level 4
CP-383, single daily oral capsule, 5.0 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Dose Level 5
CP-383, single daily oral capsule, 8.0 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Dose Level 6
CP-383, single daily oral capsule, 12 mg
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Expansion Arm 1
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Expansion Arm 2
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Expansion Arm 3
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental: Expansion Arm 4
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
Drug: CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Determine the maximum tolerated dose (MTD)
Time Frame: 21 days
Determine the MTD of CP-383 in subjects with advanced solid tumors
21 days
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
From enrollment through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Assess standard PK parameters including tmax
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
Assess standard PK parameters including AUC
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
Incidence and severity of Adverse events and changes in test results
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
Incidence of AEs and changes in test results
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
Evaluate duration of response
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
Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months
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
Evaluate progression free survival
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
Evaluate overall survival
From enrollment through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasca Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2025

Primary Completion (Estimated)

August 15, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 20, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAS-CP383-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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