Study on ASP2998 Alone and with Standard Treatments for People with Solid Tumors

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT07287995

This clinical trial is testing a new drug, ASP2998, to see if it can help treat solid tumors by itself or when combined with standard cancer treatments. The study aims to find out if ASP2998 is safe and effective in reducing tumor growth.

Patient Parameters

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Program Overview

This study is exploring a new drug called ASP2998, which targets a protein called TROP2 found in many solid tumors. ASP2998 is being tested to see if it can help attack tumor cells either on its own or when combined with standard cancer treatments like pembrolizumab, carboplatin, and enfortumab vedotin. The main goal is to check the safety of ASP2998 and how well it is tolerated by patients. The study will also look at how ASP2998 affects tumor growth and how the body processes the drug. Participants will include adults with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. The study will have two parts, with different groups receiving varying doses of ASP2998 to find the most suitable dose for further testing.

Description

This clinical trial is testing a new drug called ASP2998, which is designed to target a protein called TROP2 found in many solid tumors. The study aims to see if ASP2998 can help treat solid tumors either by itself or when combined with standard cancer treatments like pembrolizumab, carboplatin, and enfortumab vedotin. The main goal is to check the safety of ASP2998 and how well it is tolerated by patients. The study will also look at how ASP2998 affects tumor growth and how the body processes the drug.

Participants in this study will be adults with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. The study will include people with bladder cancer, non-small cell lung cancer, gastric cancer, gastroesophageal cancer, or certain types of breast cancer. People cannot take part if their cancer has spread to the brain or spinal cord, or if they need medicines to suppress their immune system.

The study will have two parts. In Part 1, small groups of participants will receive different doses of ASP2998, either by itself or with standard cancer treatments, to find suitable doses for Part 2. In Part 2, other groups will receive the doses determined in Part 1 to see how each type of cancer responds to ASP2998. Throughout the study, safety checks will be done at each visit, and doctors will monitor for any medical problems. ASP2998 will be given through an infusion into a vein, and participants will continue to receive the drug until their cancer worsens, they cannot tolerate it, or they start another cancer treatment.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body.
Have tried all available standard treatments or are not eligible for them.
Have one of the following cancers: bladder cancer, non-small cell lung cancer, gastric cancer, gastroesophageal cancer, or certain types of breast cancer.
Have not had cancer spread to the brain or spinal cord.
Have a life expectancy of at least 12 weeks.
Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have at least one measurable tumor.
Have adequate organ function as shown by lab tests.
Women must not be pregnant or breastfeeding and must agree to use contraception during the study and for a period after.
Men must agree to use contraception and not donate sperm during the study and for a period after.
Agree not to participate in another interventional study while in this study.

Exclusion Criteria

Weigh less than 40 kg.
Have active cancer spread to the brain or spinal cord.
Have a history of severe side effects from previous cancer treatments.
Have uncontrolled diabetes or other serious medical conditions.
Have active infections or require systemic treatment with steroids or other immunosuppressive medications.
Have significant heart or lung disease.
Have had major surgery recently.
Have a history of severe allergic reactions to similar drugs.
Are currently participating in another clinical trial or have received investigational therapy recently.

Locations

FACILITY	ZIP	CITY	STATE
John Theurer Cancer Center at Hackensack University Medical Center	07601	Hackensack	New Jersey
START New York Long Island	11042	New Hyde Park	New York
Tennessee Oncology	37203	Nashville	Tennessee
NEXT Virginia	22031	Fairfax	Virginia

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