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NCT07436728 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-505 in Adults With Solid Tumors
A Phase 1 study, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
NCT07436728: Recruiting Phase 1 study, sponsored by Takeda.
NCT07436728 is a Phase 1 study that is actively recruiting participants, run by Takeda. The registered enrollment target is 151 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07436728, a Phase 1 study, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
Study Summary
Solid tumors occur when cells in an organ or tissue (for example in the lung or liver) start growing out of control (cancer) and form a lump or mass of cells. These solid cancers may grow very far in the general area where they started (called locally advanced) or may spread to other parts of the body (called metastatic), and doctors may not always be able to completely remove them with surgery (called unresectable). This study is a first in human (or FIH) study, which means that this is the first time that the medicine, TAK-505, is given to a smaller group of adults with solid tumors of certain cancer types, such as stomach cancer (gastric adenocarcinoma), cancer of the large bowel (colorectal cancer or CRC), lung cancer (non-small lung cell cancer or NSCLC) and cancer in the mouth, throat or voice box (head and neck squamous cell carcinoma or HNSCC). The main aims of this study are to learn how safe TAK-505 is, how well it works, how well adults with solid tumors tolerate it and to find the dose of TAK-505 that works best with the least side effects. Other aims are to learn how TAK-505 moves through the body (pharmacokinetics (PK)), if it can shrink or slow cancer (preliminary antitumor activity) and to find out if it causes the body's defense system to react to it (immunogenicity).
Primary Outcome
DLTs are defined as specific Grade 3 and 4 hematologic and hepatic nonhematologic events or any other Grade ≥3 adverse events related to treatment that occur during the DLT evaluation period after administration of TAK-505, except events that are clearly due to the underlying disease or an extraneous cause.
Interventions
- DRUG TAK-505
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2026-05-11 |
| Est. Completion | 2030-08-18 |
| Phase | Phase 1 |
What NCT07436728 shows while recruiting
NCT07436728 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 1 intervention - of which TAK-505 is the first listed.
NCT07436728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07436728 about?
NCT07436728 is a clinical study titled "A Study of TAK-505 in Adults With Solid Tumors". Solid tumors occur when cells in an organ or tissue (for example in the lung or liver) start growing out of control (cancer) and form a lump or mass of cells. These solid cancers may grow very far in the general area where they started (called locally advanced) or may spread to other parts of the bo...
What is the current status of trial NCT07436728?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2026-05-11. Estimated completion is 2030-08-18.
What interventions are being tested in trial NCT07436728?
The interventions under investigation include: TAK-505 (DRUG).
Who is sponsoring clinical trial NCT07436728?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07436728's enrollment target sits among peer trials
151 363rd of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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