Actively Recruiting
A Study of TAK-505 in Adults With Solid Tumors
Led by Takeda · Updated on 2026-05-14
151
Participants Needed
15
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TAK-505 in Adults With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at time of consent
- Have histologically or pathologically confirmed locally advanced or metastatic solid tumors including gastric adenocarcinoma, colorectal cancer, non-small cell lung cancer, or head and neck squamous cell carcinoma
- For NSCLC, must have received platinum-based chemotherapy and PD-1/PD-L1 inhibitors if no activating mutations; for activating mutations, must have received targeted therapy plus chemotherapy and PD-1/PD-L1 inhibitors
- For colorectal cancer, must have received or be intolerant to specific chemotherapy and biological therapies
- For gastric adenocarcinoma, must have received or be intolerant to platinum/fluoropyrimidine doublet therapy and appropriate targeted treatments if HER2 or PD-L1 positive
- Confirmed PD-L1 positive status or eligible for pre-screening if unknown
- Provide a tumor tissue sample obtained within 24 months or fresh biopsy before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion by RECIST v1.1 criteria
- Adequate bone marrow, renal, and liver function as specified
- Recovery from toxic effects of previous therapy to Grade 1 or baseline except certain exceptions
- Suitable venous access for blood sampling
- Treated and asymptomatic central nervous system metastases with no current treatment or leptomeningeal disease
You will not qualify if you...
- History of autoimmune disease except specified controlled conditions like vitiligo or controlled diabetes type 1
- History of brain metastases or leptomeningeal disease unless stable and off steroids
- Significant cardiac issues within 6 months before treatment including severe heart failure, unstable angina, myocardial infarction, uncontrolled hypertension, and serious arrhythmias
- History of hepatic encephalopathy
- Active lung conditions including pneumonitis, interstitial lung disease, severe COPD, pulmonary fibrosis, or uncontrolled pleural effusions
- Active infections of Grade 2 or higher
- Oxygen saturation below 90% on room air
- Unresolved inflammatory processes within 4 weeks before treatment
- Significant gastrointestinal disorders including recent perforation, bleeding, pancreatitis, diverticulitis, or inflammatory bowel disease
- Recent live vaccines or other vaccines within specified timeframes before treatment
- History of bone marrow or solid organ transplantation with immunosuppressant use
- Known hypersensitivity to TAK-505 or related substances
- Second primary invasive malignancy not in remission for at least 3 years except certain skin and in situ cancers
- Positive tests for HIV or hepatitis B or C
- Recent use of various cancer therapies within specified washout periods
- Use of corticosteroids or immunosuppressants except specified exceptions
- Major surgery or traumatic injury within 8 weeks before treatment
- Unhealed wounds from surgery or injury
- Medical or psychiatric conditions that interfere with treatment or consent
- Positive pregnancy test or unwillingness to use contraception or forego breastfeeding
- Trial site employees or those in dependent relationships with site staff
- Vulnerable populations as defined by local regulations
- Unable or unwilling to comply with study visits and procedures
- Baseline prolonged QT interval or use of QT-prolonging medications without acceptable baseline
AI-Screening
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Trial Site Locations
Total: 15 locations
1
UCI Health
Orange, California, United States, 92868
Not Yet Recruiting
2
University of California San Diego Medical Center, La Jolla
San Diego, California, United States, 92093
Not Yet Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
4
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
5
Univeristy of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
6
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
7
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
8
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
9
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
10
Mary Crowley Cancer Center
Dallas, Texas, United States, 75230
Not Yet Recruiting
11
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
12
MD Anderson
Houston, Texas, United States, 77030
Not Yet Recruiting
13
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
14
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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