CP-383 for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2, first-in-human program using dose escalation to identify a safe and active daily oral dose of CP-383, followed by dose-expansion cohorts in selected tumor types and mutation-defined groups. Participants will take CP-383 daily until disease progression or unacceptable side effects, with weekly clinic visits for the first six weeks and visits every three weeks thereafter for safety and response monitoring. Tumor tissue or a fresh biopsy and genomic testing will be required to explore whether specific gene mutations (including FAT1 loss-of-function) predict response. The trial enrolls a variety of advanced solid tumors (excluding primary brain cancers) and includes focused cohorts such as colorectal, small cell lung, head and neck, pancreatic, bladder, and non-small cell lung cancers.

Why it matters

Who can join: the full rules

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

Where it's running

• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialists-Lake Nona
  Orlando, Florida, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Nebraska Cancer Specialists
  Omaha, Nebraska, United States Recruiting
• Carolina BioOncology Institute
  Huntersville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Tasca Therapeutics
• Email: trials@tascatx.com
• Phone: 617-430-7109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.