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Study of CP-383 for Advanced or Metastatic Solid Tumors

This study is testing a new drug called CP-383 for people with advanced or metastatic (cancer that has spread) solid tumors, including colorectal cancer, small cell lung cancer, head and neck cancer, and bladder cancer. CP-383 works by stopping cancer cells from making substances they need to grow. The main goals are to find the safest and most effective dose of CP-383 and to see if it can slow or stop cancer growth. You might be able to join if you have cancer that can be measured, are not able to take standard treatments, and are willing to provide a tumor sample. The study is looking to enroll about 150 participants.

Study design
This is an interventional study with a planned enrollment of 150 participants. It aims to first determine the maximum tolerated dose and then evaluate the drug's effectiveness.
What's involved
You would take CP-383 by mouth daily and visit the clinic weekly for the first 6 weeks for checkups and tests.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the efficacy of CP-383 from enrollment through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07030257

Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Tasca Therapeutics
~150 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:CP-383

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Determine the maximum tolerated dose (MTD)
Measured over 21 days
+1 more outcome measured

Conditions

Solid Tumor Malignancies
Colorectal Carcinoma
Small Cell Lung Cancer ( SCLC )
Head and Neck (HNSCC)
Bladder Cancer
Non-Small Cell Lung Cancer
Pancreatic Cancer, Advanced or Metastatic

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Where it's being run

13 sites across 11 states
Ohio2
Texas2
Colorado1
Florida1
Michigan1
Missouri1
Nebraska1
North Carolina1

Who to contact

Tasca Therapeutics
[email protected]
617-430-7109
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Part 1: Determine the maximum tolerated dose (MTD)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 typesFrom enrollment through study completion, an average of 1 year

    Objective response rate assessed by the investigator according to RECIST