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December 8, 2025Blood

First-in-human, open-label, Phase 1 study of a novel CD30-directed antibody-drug conjugate with a topoisomerase 1 inhibitor payload, PF-08046044 (35C), in patients with Relapsed/Refractory lymphomas: Updated safety, PK, preliminary efficacy and ctdna analysis from dose escalation

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Authors

CPChristina PohCity Of Hope National Medical CenterCMCraig H. MoskowitzUniversity of MiamiEPElizabeth H. PhillipsManchester Academic Health Science Centre

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Implication

Open-label trial shows promising efficacy and safety of topoisomerase 1 inhibitor PF-08046044 in patients with R/R Hodgkin lymphoma and peripheral T cell lymphoma, indicating its potential as a new CC

Key Points

  • To evaluate the safety, pharmacokinetics, and preliminary efficacy of PF-08046044 in patients with relapsed/refractory lymphomas.
  • First-in-human, open-label, Phase 1 study
  • Participants included 50 patients with relapsed/refractory lymphomas
  • 35C was administered every 3 weeks (Q3W) in escalating doses
  • Safety profile was manageable with 88% experiencing treatment-emergent adverse events (TEAEs)
  • Overall response rate (ORR) was 73.8% in evaluable patients
  • ctDNA reduction observed in 15/16 evaluable Hodgkin lymphoma patients

Cite This Study

Poh et al. (2025) studied this question.

synapsesocial.com/papers/69362f6c4fa91c937236dfaehttps://doi.org/10.1182/blood-2025-155
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Frontline brentuximab vedotin and CHP (A+CHP) in patients (pts) with peripheral T-cell lymphoma with less than 10% CD30 expression: Results from the phase 2 SGN35-032 study.2024 · 7 citations
  2. 2Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors.2024 · 14 citations
  3. 3Abstract CT185: A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BC3402 in advanced solid malignancies2024
  4. 4CD30 CAR-T cells in combination with anti-PD-1 camrelizumab in relapsed/refractory CD30+ lymphomas2026 · 3 citations
  5. 5Autologous CD30.CAR-T-cell therapy in patients with relapsed or refractory classical Hodgkin lymphoma – long term update of the chariot trial2025 · 2 citations