Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
150
1 country
13
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2025
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedStudy Start
First participant enrolled
August 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
February 18, 2026
January 1, 2026
3 years
May 20, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: Determine the maximum tolerated dose (MTD)
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
Objective response rate assessed by the investigator according to RECIST
From enrollment through study completion, an average of 1 year
Secondary Outcomes (9)
Part 1: Determine the pharmacokinetics parameters of CP-383
From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
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
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
From enrollment through study completion, an average of 1 year
- +4 more secondary outcomes
Study Arms (10)
Dose Level 1
EXPERIMENTALCP-383, single daily oral capsule, 0.8 mg
Dose Level 2
EXPERIMENTALCP-383, single daily oral capsule, 1.6 mg
Dose Level 3
EXPERIMENTALCP-383, single daily oral capsule, 3.0 mg
Dose Level 4
EXPERIMENTALCP-383, single daily oral capsule, 5.0 mg
Dose Level 5
EXPERIMENTALCP-383, single daily oral capsule, 8.0 mg
Dose Level 6
EXPERIMENTALCP-383, single daily oral capsule, 12 mg
Expansion Arm 1
EXPERIMENTALExpansion in selected tumor type at recommended Phase 2 Dose of CP-383
Expansion Arm 2
EXPERIMENTALExpansion in selected tumor type at recommended Phase 2 Dose of CP-383
Expansion Arm 3
EXPERIMENTALExpansion in selected tumor type at recommended Phase 2 Dose of CP-383
Expansion Arm 4
EXPERIMENTALExpansion in selected tumor type at recommended Phase 2 Dose of CP-383
Interventions
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Florida Cancer Specialists-Lake Nona
Orlando, Florida, 32827, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Washington University
St Louis, Missouri, 63110, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NEXT Oncology - Dallas
Dallas, Texas, 75039, United States
START San Antonio
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2025
First Posted
June 22, 2025
Study Start
August 27, 2025
Primary Completion (Estimated)
August 15, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
February 18, 2026
Record last verified: 2026-01