OncRef

Clinical Trial: NCT04879849

A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Takeda
Information Provided By:Takeda
Last Update Posted:2025-09-04

Study Overview

Brief Summary

In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it.

Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.

Official Title

An Open-label, Phase 1, Dose-escalation Study to Evaluate the Safety and Preliminary Antitumor Activity of TAK-676 With Pembrolizumab Following Radiation Therapy in the Treatment of Non-small-cell Lung Cancer, Triple-negative Breast Cancer, or Squamous-cell Carcinoma of the Head and Neck That Has Progressed on Checkpoint Inhibitors

Conditions

Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment

  • Drug: Pembrolizumab
  • Drug: TAK-676
  • Radiation: Image-guided radiation therapy

Other Study ID Numbers

  • TAK-676-1003
  • U1111-1252-0338

Start Date (Actual)

2021-09-09

Primary Completion Date (Actual)

2024-04-30

Study Completion Date (Actual)

2024-04-30

Enrollment (Actual)

34

Study Type

Interventional

Phase

Phase 1