Study Of CP-383 In Patients With Advanced Or Metastatic Solid Tumors

Study Overview

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

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

N/A

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

DRUG: CP-383

TAS-CP383-01

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	Results Reporting Dates	Study Record Updates
First Submitted 2025-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-03
First Submitted that Met QC Criteria 2025-06-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-04
First Posted (ESTIMATED) 2025-06-22	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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

Primary Outcome Measures	Measure Description	Time Frame
Part 1: Determine the maximum tolerated dose (MTD)	Determine the MTD of CP-383 in subjects with advanced solid tumors	21 days
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types	Objective response rate assessed by the investigator according to RECIST	From enrollment through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Part 1: Determine the pharmacokinetics parameters of CP-383	Assess standard PK parameters including Cmax	From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383	Assess standard PK parameters including tmax	From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383	Assess standard PK parameters including AUC	From enrollment through study completion, an average of 1 year
Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors	Incidence and severity of Adverse events and changes in test results	From enrollment through study completion, an average of 1 year
Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types	Incidence of AEs and changes in test results	From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types	Evaluate duration of response	From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types	Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months	From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types	Evaluate progression free survival	From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types	Evaluate overall survival	From enrollment through study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tasca Therapeutics

Phone Number: 617-430-7109

Email: trials@tascatx.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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