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

Phase 1

Recruiting

• Conditions: nresectable Locally Advanced or Metastatic Cancer; MedDRA version: 21.0Level: PTClassification code: 10061289Term: Metastatic neoplasm Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504012-16-00
• Lead Sponsor: Takeda Development Center Americas Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

01. Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable., 02. Criteria for disease state in dose escalation and cohort expansion. a. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers. b. Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms., 03. Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1., 04. Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was = 6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.

Exclusion Criteria

01. History of known autoimmune disease., 02. Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280., 03. Unhealed wounds from surgery or injury., 04. Ongoing or active infection of Grade >=2., 05. Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment., 06. Inflammatory process that has not resolved for >= 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., 07. 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., 08. Known hypersensitivity to TAK-280 or any excipient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the safety, tolerability, and DLTs of TAK-280 to determine the MTD (if any) and RP2D.;Secondary Objective: To characterize the PK of TAK-280., To evaluate the preliminary antitumor activity of TAK-280 per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1., To characterize the potential immunogenicity of TAK-280.;Primary end point(s): 01. Number of Participants With Treatment- emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 37 months], 02. Number of Participants With Dose Limiting Toxicities (DLTs). DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28. [Time Frame: From start of the initial dose up to Cycle 1 Day 28]