First-in-Human Study of TAK-280 in Patients with Solid Tumors

Sponsor: Takeda

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05220098

Provider View

This clinical trial is testing a new drug, TAK-280, to see if it is safe and how well it works in patients with advanced cancer that cannot be removed by surgery and who have not responded to standard treatments.

Patient Parameters

Program Overview

The main goal of this study is to determine if TAK-280 is safe and tolerable for patients with advanced cancer that cannot be surgically removed or has spread to other parts of the body. These patients have either not responded to or cannot tolerate standard treatments. Participants will receive TAK-280 for up to 14 cycles, with each cycle lasting 28 days. After the last dose, participants will be monitored every 12 weeks for a year to check on their survival.

Description

This study has two parts: the Dose-Escalation Phase and the Cohort-Expansion Phase.

Dose-Escalation Phase:

In this phase, researchers will test different doses of TAK-280 to find out which doses are safe and well-tolerated. The goal is to identify two recommended doses that can be used in the next phase of the study.

Cohort-Expansion Phase:

In this phase, the study will focus on three specific types of cancer. For one type, participants will be randomly assigned to receive either a high dose or a low dose of TAK-280. For the other two types of cancer, participants will receive only one dose level of TAK-280. This phase aims to further evaluate the safety and effectiveness of the drug in these specific cancer types.

Eligibility Criteria

Inclusion Criteria

  • 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 mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was >=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.

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 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 administration. Inactivated annual influenza vaccination is allowed.
  • Known hypersensitivity to TAK-280 or any excipient.

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