Washington University in St. Louis

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

Purpose

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

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Dose Level 1	CP-383, single daily oral capsule, 0.8 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Dose Level 2	CP-383, single daily oral capsule, 1.6 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Dose Level 3	CP-383, single daily oral capsule, 3.0 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Dose Level 4	CP-383, single daily oral capsule, 5.0 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Dose Level 5	CP-383, single daily oral capsule, 8.0 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Dose Level 6	CP-383, single daily oral capsule, 12 mg	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Expansion Arm 1	Expansion in selected tumor type at recommended Phase 2 Dose of CP-383	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Expansion Arm 2	Expansion in selected tumor type at recommended Phase 2 Dose of CP-383	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Expansion Arm 3	Expansion in selected tumor type at recommended Phase 2 Dose of CP-383	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Experimental Expansion Arm 4	Expansion in selected tumor type at recommended Phase 2 Dose of CP-383	Drug: CP-383 Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University
St Louis, Missouri 63110

Contact:
Sara Mitchum
314-273-8602
saram@wustl.edu

More Details

NCT ID: NCT07030257
Status: Recruiting
Sponsor: Tasca Therapeutics

Study Contact

Tasca Therapeutics
617-430-7109
trials@tascatx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.