Trial reportCancer research communications2025
A First-In-Human Study of the SUMOylation Inhibitor Subasumstat in Patients with Advanced/Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies.
Trial report 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 NCT03648372 (An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies
Who cites it
4 citing papers in PubMed.
- Mimicking mammalian hibernation to lock cancer cells in safe quiescence.Discover oncology · 2026Article
- SUMOylation in cancer: molecular mechanisms and therapeutic implications.Molecular cancer · 2026Review
- SUMOylation Inhibitor TAK-981 Alleviates Hallmark Features of Preeclampsia Related to High Glucocorticoid Exposure by Inhibiting Placental Oxidative Stress in Rats.Antioxidants (Basel, Switzerland) · 2026Article
- ROS-SUMO Crosstalk in Oxidative Stress: Disease Mechanisms and Reproductive Health.Antioxidants (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
Abstract
purposeSubasumstat (TAK-981) is a first-in-class inhibitor of SUMOylation that can engage innate and adaptive immune responses in tumors by enhancing type I IFN (IFNI) production. We conducted a phase I/II dose-escalation/-expansion study (NCT03648372) to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of subasumstat as a single agent in patients with advanced/metastatic solid tumors and relapsed/refractory hematologic malignancies. PATIENTS AND
methodsEligible patients received subasumstat intravenously at escalating doses twice weekly (days 1, 4, 8, and 11) or once weekly (days 1 and 8) in 21-day cycles until disease progression or unacceptable toxicity.
resultsA total of 109 patients were enrolled (solid tumors: n = 100; lymphomas, n = 9). In phase I, four patients reported dose-limiting toxicities of grade 3 alanine transaminase/aspartate transaminase elevation, pneumonitis, stomatitis, and cognitive disorder; 120 mg twice weekly was determined as the MTD. The most common adverse events were fatigue (47%), nausea (41%), diarrhea (36%), and pyrexia (36%). Pharmacodynamic analyses demonstrated target engagement and SUMOylation pathway inhibition, induction of an IFNI-regulated gene signature and cytokine production, and activation of innate and adaptive immune cells. Based on safety, pharmacokinetic, and pharmacodynamic findings, 90 mg twice weekly was proposed as the recommended phase II dosage. Overall, three and 26 patients achieved a partial response and stable disease, respectively.
conclusionsSubasumstat had a manageable safety profile, with evidence of innate and adaptive immune response engagement in patients with advanced/metastatic solid tumors and relapsed/refractory hematologic malignancies. Further studies are needed to determine the role of subasumstat in cancer treatment. SIGNIFICANCE: Identification of novel and effective therapies for patients who become refractory to standard anticancer treatments remains paramount. In this phase I/II study, subasumstat, a first-in-class SUMOylation inhibitor, had preliminary clinical activity and demonstrated target engagement, upregulation of IFN and plasma cytokines, and activation of innate and adaptive immune cells.
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