A Study of TAK-505 in Adults With Solid Tumors
ConditionMalignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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).
Eligibility criteria
Qualifiers
Aged greater than or equal to (≥) 18 years or ≥ the local legal age of majority, as applicable, at the time of signing the main informed consent form (ICF).
Gastric adenocarcinoma.
Colorectal cancer (CRC).
Non-small cell lung cancer (NSCLC) (both squamous and non-squamous).
Disqualifiers
History of hepatic encephalopathy.
Ongoing or active infection of Grade ≥2
Oxygen saturation <90% on room air at screening or during the C1D1 predose assessment.
Inflammatory process that has not resolved for ≥4 weeks before the first dose of trial intervention. Participants with chronic low-grade inflammatory processes such as radiation induced pneumonitis are excluded regardless of duration.
Trial design
Treatments tested in this trial
- TAK-505
Treatment groups
151 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov