First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of this study is to find out the safety and tolerability of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer failing or intolerant to standard therapies. The study consists of a dose-escalation phase to determine the recommended dose of TAK-280 for the cohort-expansion phase. Cohort-expansion phase will further define the safety and initial efficacy of TAK-280.

Participants will be treated with TAK-280 for up to 14 treatment cycles for a maximum total of 56 doses of TAK-280. Each treatment cycle will be 28 days. Participants will be treated with TAK- 280 until disease progression, unacceptable toxicity, or withdrawal from study occurs. Their cancer will be treated by their doctor according to their doctor's usual clinical practice.

After the last dose of study drug, participants will be followed up for survival every 12 weeks for at least 52 weeks.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Takeda Development Center Americas, Inc.

Criteria

Inclusion Criteria

• Age greater than or equal to (>=)18 years.

• Criteria for disease state.

1. Dose-escalation tumor histologies: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.

2. Cohort-expansion tumor histologies: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.

• Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1.

• Measurable disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 and documented by CT and/or MRI except for participants with PC with only bone metastases.

Exclusion Criteria

• History of known autoimmune disease.

• Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.

• Unhealed wounds from surgery or injury.

• Ongoing or active infection of Grade >=2.

• Oxygen saturation < 92% on room air at screening or during C1D1 predose assessment.

• Inflammatory process that has not resolved >= 4 weeks before the first dose of study drug. participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.

• Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug. Inactivated annual influenza vaccination is allowed.

• Known hypersensitivity to TAK-280 or any excipient.