Trial results for a Phase 1 study investigating pembrolizumab in combination with TAK-676 (Dazostinag) after radiation therapy for various cancers were posted on ClinicalTrials.gov on 2025-09-04. The study, which included participants with non-small-cell lung cancer, triple-negative breast cancer, and squamous-cell carcinoma of the head and neck, primarily reported on treatment-emergent adverse events (TEAEs). The highest number of participants reporting one or more TEAEs was 7 in the 2.5 mg Dazostinag dose group.
Background
The study, titled 'A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers,' aimed to evaluate the safety and tolerability of the combination of TAK-676 and pembrolizumab following radiotherapy. It focused on adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and squamous-cell carcinoma of the head and neck (SCCHN).
Trial design
The study (NCT04879849) was a Phase 1, completed trial that enrolled 34 participants. It investigated the combination of TAK-676 and pembrolizumab following radiotherapy in patients with non-small-cell lung cancer, triple-negative breast cancer, and squamous-cell carcinoma of the head and neck. Participants received radiotherapy, then at least 40 hours later received pembrolizumab followed by TAK-676 (Dazostinag) at various dose levels. The main aims included assessing the occurrence of side effects from these combined treatments and determining how much TAK-676 participants could receive without unacceptable side effects.
Key results
The trial results focused on the number of participants reporting one or more treatment-emergent adverse events (TEAEs). For the outcome titled 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity,' the following counts were observed across various treatment groups:
- In the Radiation + Pembrolizumab + Dazostinag 0.2 mg group, 4 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 0.4 mg group, 2 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 0.8 mg group, 4 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 1.6 mg group, 3 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 2.5 mg group, 7 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 3.5 mg group, 5 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 5.0 mg group, 6 participants reported TEAEs.
- In the Radiation Only group, 2 participants reported TEAEs.
Separate measurements for the same outcome title also reported:
- In the Radiation + Pembrolizumab + Dazostinag 0.2 mg group, 0 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 0.4 mg group, 1 participant reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 0.8 mg group, 4 participants reported TEAEs.
- In the Radiation + Pembrolizumab + Dazostinag 1.6 mg group, 1 participant reported TEAEs.
What this means
The posted results from this Phase 1 study provide initial safety data for the combination of pembrolizumab and TAK-676 (Dazostinag) following radiation therapy in patients with advanced cancers. The reported counts of treatment-emergent adverse events across different dose levels of Dazostinag contribute to understanding the safety profile of this combination. These findings are crucial for informing potential future development and dose selection for subsequent clinical trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04879849, titled 'A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers,' were posted on 2025-09-04 on clinicaltrials.gov.