Brief Title: CP-383 in Patients With Advanced or Metastatic Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1: Determine the maximum tolerated dose (MTD)

Primary Outcome 1 - Timeframe: 21 days

Primary Outcome 2 - Measure: Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

Primary Outcome 2 - Timeframe: From enrollment through study completion

CONDITION

• 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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Tasca Therapeutics

Phone: 617-430-7109

Email: [email protected]

LOCATION