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First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
EU CTIS ID: 2023-504012-16-00
What this study is testing
To characterize the safety, tolerability, and DLTs of TAK-280 to determine the MTD (if any) and RP2D.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.