ArticleCancer research communications2025
Phase 1b Study of Dazostinag plus Pembrolizumab after Hypofractionated Radiotherapy in Patients with Select Advanced Solid Tumors.
Article in Cancer research communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04879849 (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), which is not on this map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
5 citing papers in PubMed.
- cGAS-STING pathway activation drives the cold-to-hot tumor transition and sensitizes immunotherapy.Cancer biology & medicine · 2026Review
- Endobronchial Intratumoral Immuno- and Gene Therapies in Lung Cancer: Mechanisms of Local Delivery, Systemic Immune Effects, and Global Feasibility.International journal of molecular sciences · 2026Review
- Therapeutic targeting of the cGAS-STING pathway in human disease.The Journal of clinical investigation · 2026Review
- The cGAS-STING pathway in cancer: friend or foe.Cell death & disease · 2026Review
- Optimizing immunotherapy-radiotherapy synergy in triple-negative breast cancer: mechanisms, clinical evidence, and therapeutic windows.Frontiers in immunology · 2026Review
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27 authors.
Funding
Abstract
purposeWe present the preclinical rationale and clinical data from a phase 1b trial investigating the STING agonist dazostinag plus pembrolizumab following hypofractionated radiotherapy (RT) in patients with advanced non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or squamous cell carcinoma of the head and neck (SCCHN) whose disease had progressed on prior checkpoint inhibitors (CPI; NCT04879849). PATIENTS AND
methodsEligible patients received radiation (8 Gy × 3 fractions) followed (≥40 hours) by pembrolizumab 200 mg every 3 weeks and dazostinag in escalating doses (0.2-5.0 mg). Primary endpoints were safety and tolerability. Secondary endpoints included preliminary antitumor activity in irradiated and nonirradiated lesions, pharmacokinetic analyses, and pharmacodynamic analyses.
resultsPreclinical studies demonstrated tumor control and enhanced intratumoral immune activation in mice treated with dazostinag plus radiation. Thirty-four patients (NSCLC: 15, SCCHN: 10, and TNBC: 9) with a median number of six prior treatments were enrolled. Thirty-three (97.1%) patients reported treatment-emergent adverse events (TEAE), none were dose-limiting toxicities; the most common were fatigue (52.9%), constipation (26.5%), and cough (20.6%). Dazostinag-related TEAEs occurred in 17 patients (50.0%); the most common were fatigue (26.5%), chills (8.8%), diarrhea, arthralgia, and myalgia (5.9% each). Antitumor activity, per RECIST v.1.1, was confirmed in two (7.1%) patients (one complete response and one partial response). Pharmacodynamic analyses indicated activation of STING and IFNγ pathways across multiple dose levels and induced immune responses, consistent with preclinical studies.
conclusionsDazostinag, combined with pembrolizumab after RT, was well tolerated and demonstrated clinical activity in some patients with advanced/metastatic tumors whose disease had progressed on CPIs. SIGNIFICANCE: Dazostinag, an intravenous STING agonist, combined with radiation, demonstrated tumor control and enhanced intratumoral immune activation, preclinically. In phase 1b, dazostinag plus pembrolizumab following RT had a manageable safety profile and provided clinical benefit for some heavily pretreated patients with advanced/metastatic solid tumors whose disease had progressed on CPIs.
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