Recruiting

Phase 1

Phase 2

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

Sponsor:

Tasca Therapeutics

Code:

NCT07030257

Conditions

Solid Tumor Malignancies

Colorectal Carcinoma

Small Cell Lung Cancer ( SCLC )

Head and Neck (HNSCC)

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CP-383

Study Details

Brief summary:

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

Study ID

NCT07030257

Start date

Aug 27, 2025

Status verified date

Jan, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Aug 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Level 1

CP-383, single daily oral capsule, 0.8 mg

experimental: Dose Level 2

CP-383, single daily oral capsule, 1.6 mg

experimental: Dose Level 3

CP-383, single daily oral capsule, 3.0 mg

experimental: Dose Level 4

CP-383, single daily oral capsule, 5.0 mg

experimental: Dose Level 5

CP-383, single daily oral capsule, 8.0 mg

experimental: Dose Level 6

CP-383, single daily oral capsule, 12 mg

experimental: Expansion Arm 1

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

experimental: Expansion Arm 2

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

experimental: Expansion Arm 3

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

experimental: Expansion Arm 4

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Interventions

CP-383

Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Primary outcome measure

Part 1: Determine the maximum tolerated dose (MTD) [ Time Frame: 21 days ]
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types [ Time Frame: From enrollment through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Tasca Therapeutics

617-430-7109 trials@tascatx.com

Locations

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Contacts

HealthOne Denver

720-754-2610 cann.ddudenvergeneral@sarahcannon.com

Principal Investigator:

Gerald Falchook, MD

Florida Cancer Specialists-Lake Nona

Recruiting

Orlando, Florida, United States, 32827

Contacts

Elizabeth Gilmore

904-380-2410 elizabeth.griffith@scri.com

Principal Investigator:

Cesar Perez, MD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Colleen Armstrong

616-389-1905 colleen.armstrong@startresearch.com

Principal Investigator:

Sreenivasa Chandana, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Mitchum

314-273-8602 saram@wustl.edu

Principal Investigator:

Nikolaos Trikalinos, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Ashley Servais

402-955-2691 aservais@nebraskacancer.com

Principal Investigator:

Ralph Hauke, MD

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Hannah Wall

980-441-1148 hwall@carolinabiooncology.org

Principal Investigator:

Neel Gandhi, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Taussig Research

216-444-7923 TaussigResearch@ccf.org

Principal Investigator:

Alex Adjei, MD

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Stephanie Ambrose, RN, BSN, CCRC

567-402-4502 SAmbrose@tcrcpt.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Roger Cohen, MD

215-662-4469 roger.cohen@pennmedicine.upenn.edu

Principal Investigator:

Roger Cohen, MD

NEXT Oncology - Dallas

Recruiting

Dallas, Texas, United States, 75039

Contacts

Mofopefoluwa Akinwale

972-893-8800 fakinwale@nextoncology.com

Principal Investigator:

Michael Song, MD, PhD, PharmD

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez

210-593-5265 isabel.jimenez@startresearch.com

Principal Investigator:

Kyriakos P. Papadopoulos, MD

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Marie Asay

801-907-4770 marie.asay@startresearch.com

Principal Investigator:

William McKean, MD, PhD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518 mdelarosa@nextoncology.com

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

Tasca Therapeutics

Last update posted

Feb 18, 2026

Last verified

Jan, 2026

Keywords

Phase 1
Dose Escalation
Dose Expansion
Loss of Function
FAT1
P300

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tasca Therapeutics on 2026-02-18.