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).
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Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Clinically Significant Laboratory Values and Vital Signs
Timeframe: From first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)
Phase 2 Dose Expansion: Confirmed Overall Response Rate (ORR)
Timeframe: Up to end of study (up to approximately 52 months)
Phase 2 Dose Expansion: Number of Participants With TEAEs, Clinically Significant Laboratory Values and Vital Signs
Timeframe: From first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)