New pill takes aim at Hard-to-Treat cancers
NCT ID NCT07030257
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This trial tests an experimental drug called CP-383 in people with advanced solid tumors (like lung, colon, or pancreatic cancer) that have not responded to standard treatments. The drug is taken daily by mouth and works by blocking a process cancer cells need to grow. The study has two parts: first, finding the safest dose, and then checking if that dose shrinks tumors in specific cancer types. About 150 participants will be enrolled across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CP-383 (a drug that blocks a key step cancer cells need to make new DNA)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced cancers that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 150 participants, so the drug may not work or may cause serious side effects. It is too soon to know if it will help.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced or metastatic solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Carolina BioOncology Institute
RECRUITINGHuntersville, North Carolina, 28078, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Florida Cancer Specialists-Lake Nona
RECRUITINGOrlando, Florida, 32827, United States
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NEXT Oncology - Dallas
RECRUITINGDallas, Texas, 75039, United States
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NEXT Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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Nebraska Cancer Specialists
RECRUITINGOmaha, Nebraska, 68130, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START Mountain Region
RECRUITINGWest Valley City, Utah, 84119, United States
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START San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
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Taylor Cancer Research Center
RECRUITINGMaumee, Ohio, 43537, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Oral drug that targets two cancer drivers tested in first human study
- Dutch bladder cancer cohort aims to map survival and recurrence
- Experimental pill HG146 put to the test against rare head and neck cancer
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?