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

Launched by TASCA THERAPEUTICS · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CP-383 to see if it can help slow down or stop the growth of advanced cancers. Researchers also want to learn how safe CP-383 is and what side effects it might cause. The study is for adults with certain types of advanced or spreading solid tumors, including cancers like colorectal, lung, head and neck, bladder, and pancreatic cancer. Some participants’ tumors will also be tested to see if specific gene changes make the drug work better.

If you join the trial, you would take CP-383 as a pill every day. You’ll visit the clinic once a week for the first six weeks and then every three weeks after that for checkups and tests to monitor how the treatment is working and how you’re feeling. To be eligible, you need to have advanced cancer that can be measured or checked by doctors, have no other good treatment options, and be willing to have a tumor sample tested or safely taken. People with certain health problems, brain tumors, or who are pregnant cannot join. This trial is not yet recruiting but aims to find the best dose and learn which patients might benefit most from CP-383.

Gender

ALL

Eligibility criteria

• 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