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NCT07287995 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
A Phase 1 study of Locally Advanced or Metastatic Malignant Solid Tumors, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 428
- Enrollment target
- 3
- Study locations
NCT07287995 is a Phase 1 study of Locally Advanced or Metastatic Malignant Solid Tumors that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 428 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT07287995, a Phase 1 study of Locally Advanced or Metastatic Malignant Solid Tumors, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 428 participants
- Enrollment target
- 3
- Study locations
Study Summary
Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin, and enfortumab vedotin. This is an early development study to collect information about ASP2998 in people with solid tumors. In this study ASP2998 will be given to humans for the first time. Early development studies are mostly about safety, but also to find the most suitable dose. Other aims are to check if ASP2998 shows signs of reducing tumor growth, to learn how the body processes ASP2998, and to check if there are changes either in the TROP2 protein or in the immune system. The main aim of the study is to check the safety of ASP2998 when given by itself and given with the standard cancer treatments, and how well it is tolerated. People in this study will be adults with locally advanced, unresectable or metastatic solid tumors. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. People's cancer came back or became worse after previous treatment or they couldn't receive treatment. Some people who had previously refused treatment may be able to take part. This will depend on which study treatment they receive. People will either have cancer in the bladder lining (urothelial cancer), non-small cell lung cancer (NSCLC), gastric cancer or cancer where the food pipe joins the stomach (gastroesophageal cancer, or GEJ), or certain types of breast cancer. People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or need medi
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG ASP2998
- DRUG Enfortumab Vedotin
Study Locations (3)
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
New York
- START New York Long Island - New Hyde Park
Tokyo
- National Cancer Center Hospital - Chuo-ku
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2026-02-05 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07287995
The ClinicalTrials.gov registry entry for NCT07287995 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 428 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Locally Advanced or Metastatic Malignant Solid Tumors appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT07287995 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New Jersey, New York, Tokyo.
Frequently Asked Questions
What is clinical trial NCT07287995 about?
NCT07287995 is a clinical study titled "A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors". Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given to...
What is the current status of trial NCT07287995?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 428 participants. The study started on 2026-02-05. Estimated completion is 2029-06-30.
What conditions does trial NCT07287995 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Malignant Solid Tumors.
What interventions are being tested in trial NCT07287995?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), ASP2998 (DRUG), Enfortumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT07287995?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07287995 being conducted?
This trial has 3 study locations across New Jersey, New York, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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