CTIS2023-504012-16-00
Recruiting
Phase 1
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer - TAK-280-1501
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nresectable Locally Advanced or Metastatic Cancer
- Sponsor
- Takeda Development Center Americas Inc.
- Enrollment
- 129
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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