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RECRUITING Phase 1

A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors

NCT07094204 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 364 participants
Start Date 2025-07-25
Est. Completion 2029-04-30
Phase Phase 1

Sponsor

Astellas Pharma

51 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07094204

The ClinicalTrials.gov registry entry for NCT07094204 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 364 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which ASP5834 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07094204 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Other, Georgia, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Colorectal Cancer, Solid Tumor, Pancreatic Ductal Adenocarcinoma, Non-Small-Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07094204?

The interventions under investigation include: ASP5834 (DRUG), panitumumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07094204?

This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial