A Study of TAK-505 in Adults With Solid Tumors

Conditions

• Malignant Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-505 — DRUG
  Participants will receive TAK-505 intravenously (IV)

Study Details

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).

Key Dates

Start date

May 11, 2026

Status verified

May 2026

Primary completion

Aug 18, 2030

Completion

Aug 18, 2030

Study Design

Enrollment

151 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: TAK-505 Dose Escalation
  Participants will receive TAK-505 intravenous (IV) infusion until disease progression intolerability, or any other treatment discontinuation criterion is met.
• Experimental: Phase 2: TAK-505 Dose Expansion
  Participants with up to 3 selected tumor indications will receive the recommended dose for expansion (RDE) until disease progression intolerability, or any other treatment discontinuation criterion is met.

Primary Outcome Measure

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (15)

Find similar trials in Orange, CA

Related Studies

• Characterization of Hyperpolarized Pyruvate MRI Reproducibility
  Recruiting · Memorial Sloan Kettering Cancer Center · Montvale, New Jersey
• Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas