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TAK-280 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers are eligible for dose escalation
Eastern Cooperative Oncology Group performance status less than or equal to 1
Must not have
Ongoing or active infection of Grade greater than or equal to 2
Unhealed wounds from surgery or injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 37 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug (TAK-280) to see if it can treat cancer that hasn’t responded to other treatments. Participants will be tested for 48 weeks.
Who is the study for?
This trial is for adults with advanced or metastatic cancer who haven't responded to standard treatments or can't tolerate them. They should be relatively active (with a good performance status), have measurable disease, and not have had major surgery recently. People with known allergies to TAK-280, autoimmune diseases, recent live vaccines, ongoing infections, low oxygen levels without support, or unresolved wounds are excluded.
What is being tested?
The study tests the safety and effects of a new cancer drug called TAK-280 over up to 14 cycles of treatment (each cycle lasts 28 days). The goal is to see how well participants tolerate this drug and what impact it has on their cancer when other treatments have failed.
What are the potential side effects?
While specific side effects for TAK-280 aren't listed here, common side effects in trials like this may include reactions at the injection site, fatigue, nausea, increased risk of infection due to immune system suppression by the drug itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be removed by surgery.
Select...
I can carry out all my usual activities without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a serious or uncontrolled infection.
Select...
I have wounds from surgery or injury that have not healed.
Select...
I have not had major surgery or serious injury within the last 8 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 37 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary study objectives
Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280
Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Disease Control Rate
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose-escalation Phase: TAK-280Experimental Treatment1 Intervention
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.
Group II: Cohort-expansion Phase: TAK-280 High or low DoseExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
TakedaLead Sponsor
1,240 Previous Clinical Trials
4,147,495 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,591 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
500,536 Total Patients Enrolled