NCT07436728

A Study of TAK-505 in Adults With Solid Tumors

A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 151 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	TAK-505	Participants will receive TAK-505 intravenously (IV)

Timeline

• Start date: 2026-04-15
• Primary completion: 2030-08-18
• Completion: 2030-08-18
• First posted: 2026-02-27
• Last updated: 2026-03-27

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study