Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
NCT ID: NCT07030257
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2025-08-27
2029-02-28
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Level 1
CP-383, single daily oral capsule, 0.8 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Dose Level 2
CP-383, single daily oral capsule, 1.6 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Dose Level 3
CP-383, single daily oral capsule, 3.0 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Dose Level 4
CP-383, single daily oral capsule, 5.0 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Dose Level 5
CP-383, single daily oral capsule, 8.0 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Dose Level 6
CP-383, single daily oral capsule, 12 mg
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Expansion Arm 1
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Expansion Arm 2
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Expansion Arm 3
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Expansion Arm 4
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Interventions
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CP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tasca Therapeutics
INDUSTRY
Responsible Party
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Locations
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Florida Cancer Specialists-Lake Nona
Orlando, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
NEXT Oncology - Dallas
Dallas, Texas, United States
START San Antonio
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TAS-CP383-01
Identifier Type: -
Identifier Source: org_study_id
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