Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study consists of 2 phases: dose escalation and cohort expansion. The objective of the Dose Escalation Phase is to determine the recommended dose of TAK-280 for the cohort expansion phase. The Cohort Expansion Phase will consist of 5 separate participant cohorts, based on their cancer type. TAK-280 will be administered via intravenous infusion (IV) for up to 14 treatment cycles.
Conditions
This trial is treating people with unresectable, locally advanced or metastatic cancer
Eligibility
Exclusion
- 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. Inactivated annual influenza vaccination is allowed.
- Known hypersensitivity to TAK-280 or any excipient.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Takeda
Scientific Title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Cancer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information