Status:
TERMINATED
First-in-Human Study of TAK-280 in Participants With Solid Tumors
Lead Sponsor:
Takeda
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Conditions:
Unresectable Locally Advanced or Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failu...
Detailed Description
This study consists of 2 phases: Dose-escalation and cohort-expansion phase. Dose-escalation phase: The purpose of the dose-escalation phase is to generate data to characterize the initial safety an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age greater than or equal to (\>=)18 years or \>= the local legal age of majority, as applicable.
- Criteria for disease state in dose escalation and cohort expansion.
- Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
- Tumor histologies during cohort expansion: 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 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
- 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 less than (\<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
- 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.
- Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
- Known hypersensitivity to TAK-280 or any excipient.
Exclusion
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05220098
Start Date
April 22 2022
End Date
July 28 2025
Last Update
August 29 2025
Active Locations (23)
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1
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of California San Francisco
San Francisco, California, United States, 94143
3
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
4
Duke Cancer Institute
Durham, North Carolina, United States, 27710