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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 37 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

My cancer is advanced and cannot be removed by surgery.

Select...

I can carry out all my usual activities without help.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 37 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Dose Limiting Toxicities (DLTs)

Number of Participants With Treatment- emergent Adverse Events (TEAEs)

Secondary outcome measures

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

+14 more

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,762 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,852 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,090 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this trial?

"This trial is taking place in multiple locations, such as The Cleveland Clinic Foundation in Cleveland, Cabrini Health in Malvern and Southern Oncology Clinical Research Unit in Bedford Park. Other sites include 5 additional medical centres."

Answered by AI

What is the sample size of this clinical trial?

"Affirmative. According to data featured on clinicaltrials.gov, this research is still open for recruitment with an initial posting date of April 22nd 2022 and most recent update occurring November 2st 2023. The trial seeks 182 patients from 5 different medical centres."

Answered by AI

Is there an opportunity to join this research experiment?

"Yes, it is evident from the information provided on clinicaltrials.gov that this experiment is currently looking for volunteers. It was initially made public on April 22nd 2022 and has since been updated several times, with the latest edit being published November 2nd 2023. This medical study requires 182 individuals to be recruited from 5 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer

2022. "First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05220098.