Solid Tumor MalignanciesPhase 1/2NCT07030257
Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing CP-383 in people with Solid Tumor Malignancies and Colorectal Carcinoma, run by Tasca Therapeutics at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Colorectal Carcinoma, Small Cell Lung Cancer ( SCLC )
- What is being tested?
- CP-383
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Aug 2025to Feb 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Taussig Research, 216-444-7923, TaussigResearch@ccf.org
Alex Adjei, MD
- Recruiting
NEXT Oncology - Dallas
Dallas, Texas, 75039
Mofopefoluwa Akinwale, 972-893-8800, fakinwale@nextoncology.com
Michael Song, MD, PhD, PharmD
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
HealthOne Denver, 720-754-2610, cann.ddudenvergeneral@sarahcannon.com
Gerald Falchook, MD
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Alexander Spira, MD
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Colleen Armstrong, 616-389-1905, colleen.armstrong@startresearch.com
Sreenivasa Chandana, MD
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Hannah Wall, 980-441-1148, hwall@carolinabiooncology.org
Neel Gandhi, MD
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Stephanie Ambrose, RN, BSN, CCRC, 567-402-4502 ext. 7502, SAmbrose@tcrcpt.org
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Ashley Servais, 402-955-2691, aservais@nebraskacancer.com
Ralph Hauke, MD
- Recruiting
Florida Cancer Specialists-Lake Nona
Orlando, Florida, 32827
Elizabeth Gilmore, 904-380-2410, elizabeth.griffith@scri.com
Cesar Perez, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Roger Cohen, MD, 215-662-4469, roger.cohen@pennmedicine.upenn.edu
Roger Cohen, MD
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Isabel Jimenez, 210-593-5265, isabel.jimenez@startresearch.com
Kyriakos P. Papadopoulos, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Sara Mitchum, 314-273-8602, saram@wustl.edu
Nikolaos Trikalinos, MD
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Marie Asay, 801-907-4770, marie.asay@startresearch.com
William McKean, MD, PhD
About this study
Official title: 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
Read more
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
- Conditions
- Solid Tumor Malignancies, Colorectal Carcinoma, Small Cell Lung Cancer ( SCLC ), Head and Neck (HNSCC), Bladder Cancer, Non-Small Cell Lung Cancer
- Being tested
- CP-383
- Keywords
- Phase 1, Dose Escalation, Dose Expansion, Loss of Function, FAT1, P300
- Medical subject headings
- Colorectal Neoplasms, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urinary Bladder Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-383Drug
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | CP-383, single daily oral capsule, 0.8 mg Receives: Drug: CP-383 |
| Dose Level 2 | Experimental | CP-383, single daily oral capsule, 1.6 mg Receives: Drug: CP-383 |
| Dose Level 3 | Experimental | CP-383, single daily oral capsule, 3.0 mg Receives: Drug: CP-383 |
| Dose Level 4 | Experimental | CP-383, single daily oral capsule, 5.0 mg Receives: Drug: CP-383 |
| Dose Level 5 | Experimental | CP-383, single daily oral capsule, 8.0 mg Receives: Drug: CP-383 |
| Dose Level 6 | Experimental | CP-383, single daily oral capsule, 12 mg Receives: Drug: CP-383 |
| Expansion Arm 1 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 Receives: Drug: CP-383 |
| Expansion Arm 2 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 Receives: Drug: CP-383 |
| Expansion Arm 3 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 Receives: Drug: CP-383 |
| Expansion Arm 4 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 Receives: Drug: CP-383 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Determine the maximum tolerated dose (MTD)
Determine the MTD of CP-383 in subjects with advanced solid tumors
Measured: 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
Measured: From enrollment through study completion, an average of 1 year
Secondary outcomes (9)
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including Cmax
Measured: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including tmax
Measured: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including AUC
Measured: 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
Incidence and severity of Adverse events and changes in test results
Measured: 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
Incidence of AEs and changes in test results
Measured: 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
Evaluate duration of response
Measured: 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
Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months
Measured: 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
Evaluate progression free survival
Measured: 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
Evaluate overall survival
Measured: From enrollment through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start27 Aug 2025
- Primary completion15 Aug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasca Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030257
- Sponsor's protocol ID
- TAS-CP383-01
- Status last verified
- Jan 2026
- First submitted
- 20 May 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07030257
- Acronym / sponsor ID
- TAS-CP383-01
- Conditions
- Solid Tumor Malignancies, Colorectal Carcinoma, Small Cell Lung Cancer ( SCLC ), Head and Neck (HNSCC), Bladder Cancer, Non-Small Cell Lung Cancer
- Keywords
- Phase 1, Dose Escalation, Dose Expansion, Loss of Function, FAT1, P300
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tasca TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 0.8 mg |
| Dose Level 2 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 1.6 mg |
| Dose Level 3 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 3.0 mg |
| Dose Level 4 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 5.0 mg |
| Dose Level 5 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 8.0 mg |
| Dose Level 6 | Experimental | Drug: CP-383CP-383, single daily oral capsule, 12 mg |
| Expansion Arm 1 | Experimental | Drug: CP-383Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
| Expansion Arm 2 | Experimental | Drug: CP-383Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
| Expansion Arm 3 | Experimental | Drug: CP-383Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
| Expansion Arm 4 | Experimental | Drug: CP-383Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-383Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Expansion Arm 1, Expansion Arm 2, Expansion Arm 3, Expansion Arm 4 |
Primary outcome
Part 1: Determine the maximum tolerated dose (MTD)
Time frame: 21 days
Determine the MTD of CP-383 in subjects with advanced solid tumors
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CP-383 in people with Solid Tumor Malignancies and Colorectal Carcinoma, run by Tasca Therapeutics at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasca Therapeutics (617-430-7109, trials@tascatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Determine the maximum tolerated dose (MTD) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.