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New pill takes aim at Hard-to-Treat cancers

NCT ID NCT07030257

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Carolina BioOncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Florida Cancer Specialists-Lake Nona

    RECRUITING

    Orlando, Florida, 32827, United States

  • NEXT Oncology - Dallas

    RECRUITING

    Dallas, Texas, 75039, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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