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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.

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