A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
NCT04879849 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-09-04
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.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Triple Negative Breast Neoplasms
- Squamous Cell Carcinoma of Head and Neck
Interventions
- DRUG
-
IV infusion.
- DRUG
-
TAK-676
IV infusion.
- RADIATION
-
Image-guided radiation therapy
Radiation therapy.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-09
- Primary Completion
- 2024-04-30
- Completion
- 2024-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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