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Recruiting Phase 1Phase 2 Interventional

A Study of TAK-505 in Adults With Solid Tumors

ClinicalTrials.gov ID: NCT07436728

Public ClinicalTrials.gov record NCT07436728. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07436728
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Takeda
Industry
Enrollment
151 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 10, 2026
Primary completion
Aug 17, 2030
Completion
Aug 17, 2030
Last update posted
May 13, 2026

2026 – 2030

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
13
Facility City State ZIP Site status
UCI Health Orange California 92868 Not yet recruiting
University of California San Diego Medical Center, La Jolla San Diego California 92093 Not yet recruiting
University of California San Francisco San Francisco California 94143 Not yet recruiting
H Lee Moffitt Cancer Center Tampa Florida 33612 Not yet recruiting
Univeristy of Minnesota Minneapolis Minnesota 55455 Not yet recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Not yet recruiting
Cleveland Clinic Foundation Cleveland Ohio 44195 Not yet recruiting
Sarah Cannon Research Institute SCRI Nashville Tennessee 37203 Not yet recruiting
Tennessee Oncology Nashville Tennessee 37203 Not yet recruiting
Mary Crowley Cancer Center Dallas Texas 75230 Not yet recruiting
Baylor College of Medicine Houston Texas 77030 Not yet recruiting
MD Anderson Houston Texas 77030 Not yet recruiting
NEXT Oncology San Antonio Texas 78229 Recruiting
NEXT Oncology Fairfax Virginia 22031 Recruiting
Seattle Cancer Care Alliance Seattle Washington 98109 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07436728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07436728 live on ClinicalTrials.gov.

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