RECRUITING

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

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 Phase 1 Dose Escalation Dose Expansion Loss of Function FAT1 P300

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2025-08-27

Study Completion:2029-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07030257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	* 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

Inclusion Criteria

Exclusion 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
* 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

* 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

Contacts and Locations

Study Contact

Tasca Therapeutics

CONTACT

617-430-7109

trials@tascatx.com

Study Locations (Sites)

Taylor Cancer Research Center

Maumee, Ohio, 43537

United States

Collaborators and Investigators

Sponsor: Tasca Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27

Study Completion Date2029-02

Study Record Updates

Study Start Date2025-08-27

Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

Phase 1
Dose Escalation
Dose Expansion
Loss of Function
FAT1
P300

Additional Relevant MeSH Terms

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