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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2026
  • participants needed
    186
  • sponsor
    Takeda
Updated on 15 May 2022

Summary

The main aim of this study is to find out the safety and tolerability of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer failing or intolerant to standard therapies. The study consists of a dose-escalation phase to determine the recommended dose of TAK-280 for the cohort-expansion phase. Cohort-expansion phase will further define the safety and initial efficacy of TAK-280.

Participants will be treated with TAK-280 for up to 14 treatment cycles for a maximum total of 56 doses of TAK-280. Each treatment cycle will be 28 days. Participants will be treated with TAK- 280 until disease progression, unacceptable toxicity, or withdrawal from study occurs. Their cancer will be treated by their doctor according to their doctor's usual clinical practice.

After the last dose of study drug, participants will be followed up for survival every 12 weeks for at least 52 weeks.

Description

This study consists of 2 phases: Dose-escalation and cohort-expansion phase.

Dose-escalation phase:

Dose escalation will be conducted in participants with histologically proven, unresectable, locally advanced or metastatic cancers and the Bayesian Optimal Interval (BOIN) design will be used.

Cohort-Expansion Phase:

During the cohort-expansion phase, 5 separate participant cohorts will be enrolled, based on the tumor type. The dosing regimen used in the expansion cohorts will be the recommended phase 2 dose (RP2D) and schedule based on the safety, pharmacokinetics (PK), and antitumor activity findings from the dose-escalation phase of the study.

Enrollment into the expansion cohorts is based on a Simon 2-stage design.

Details
Condition Unresectable Locally Advanced or Metastatic Cancer
Treatment TAK-280
Clinical Study IdentifierNCT05220098
SponsorTakeda
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age greater than or equal to (>=)18 years
Criteria for disease state
Dose-escalation tumor histologies: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers
Cohort-expansion tumor histologies: 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 modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 and documented by CT and/or MRI except for participants with PC with only bone metastases

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 < 92% on room air at screening or during C1D1 predose assessment
Inflammatory process that has not resolved >= 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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