First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
Unresectable Locally Advanced or Metastatic Cancer
About this trial
This is an interventional treatment trial for Unresectable Locally Advanced or Metastatic Cancer
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to (>=)18 years.
Criteria for disease state.
- Dose-escalation tumor histologies: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
- 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.
Sites / Locations
- Southern Oncology Clinical Research UnitRecruiting
- Monash Medical CentreRecruiting
- Cabrini HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dose-escalation Phase: TAK-280
Cohort-expansion Phase: TAK-280 High or low Dose
Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.