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NCT07094204 · ClinicalTrials.gov registry record · Phase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Astellas Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 364
- Enrollment target
- 12
- Study locations
NCT07094204: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Astellas Pharma.
NCT07094204 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by Astellas Pharma. The registered enrollment target is 364 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (44% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094204, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by Astellas Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 364 participants
- Enrollment target
- 12
- Study locations
Study Summary
Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment. The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab. People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. 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. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain. In this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab. This study will be in 2 parts: Part 1 is called
Primary Outcome
A DLT is defined as any Adverse Event (AE) which meets DLT criteria, not clearly due to the underlying disease or extraneous causes, that occurs within the DLT observation period.
Conditions Studied
Interventions
- DRUG ASP5834
- DRUG panitumumab
Study Locations (12)
Other
- Site FR33001 - Villejuif
- Site ES34001 - Madrid
- Site ES34003 - Madrid
Georgia
- Winship Cancer Institute at Emory University - Atlanta
Michigan
- START Midwest - Grand Rapids
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- NEXT Oncology Dallas - Irving
Virginia
- NEXT Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 1 |
What NCT07094204 shows while recruiting
NCT07094204 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (44% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which ASP5834 is the first listed.
NCT07094204 lists 12 locations in 10 states (Other, Georgia, Michigan).
Frequently Asked Questions
What is clinical trial NCT07094204 about?
NCT07094204 is a clinical study titled "A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors". Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with ...
What is the current status of trial NCT07094204?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 364 participants. The study started on 2025-07-25. Estimated completion is 2029-04-30.
What conditions does trial NCT07094204 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT07094204?
The interventions under investigation include: ASP5834 (DRUG), panitumumab (DRUG).
Who is sponsoring clinical trial NCT07094204?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094204 being conducted?
This trial has 12 study locations across Georgia, Michigan, Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07094204's enrollment target sits among peer trials
364 106th of 454 higher than 348 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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