InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 2 February 2024

TAK-280: This phase I/II dose escalation and expansion study is trying to understand how safe and effective a new drug (TAK-280) is in people with locally advanced or metastatic cancer that is unable to be removed with surgeryA Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer

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 patients with unresectable, locally advanced or metastatic cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

TAK-280

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Eligibility

Inclusion

  • Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable.

  • Criteria for disease state in dose escalation and cohort expansion.

    1. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
    2. Tumor histologies during cohort expansion: 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 RECIST V1.1 by investigator except for participants with PC and only bone metastases (these participants are allowed in the study).

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

  • 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.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Cancer Connect

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

Cancer Council’s cancer nurses

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

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.