Study to Evaluate the Safety, Efficacy, and Dosage of the New Drug PF-08046044/SGN-35C in Patients with Advanced Lymphoma

Lymphomas are cancers of the lymphatic system, which is part of the immune system. In lymphoma, these cells become abnormal and grow uncontrollably. These abnormal cells can spread throughout the body, for example to the lymph nodes, the spleen, or the bone marrow. The course of the disease and treatment options depend heavily on the specific type of lymphoma and the stage of the disease. Advanced cancers refer to lymphomas that have invaded vital organs, grow particularly aggressively, or no longer respond to previous treatments. New targeted therapies are urgently needed for such cases.

PF-08046044/SGN-35C is a so-called antibody-drug conjugate (ADC) that specifically binds to the surface marker CD30, which is present in many lymphomas. It combines an antibody with a cytotoxic agent (TOP1 inhibitor) to selectively destroy cancer cells.

The goal of the study is to evaluate the safety, tolerability, and optimal dosage of the new drug PF-08046044/SGN-35C in patients with various forms of advanced lymphoma. In addition, the study will investigate how well the drug is absorbed by the body, how long it remains in the body, and what its effects are. The study is divided into three consecutive phases. In the first phase (dose escalation), researchers will determine the safe dosage of the new active ingredient PF-08046044/SGN-35C. During this phase, patients will receive increasing amounts of the drug to determine the maximum tolerated dose. In the second part (dose optimization), the study will further examine which dose and which interval between doses are most appropriate. This is followed by the third part (dose expansion), in which the previously determined optimal dose is administered to a larger group of patients. Assignment to the respective phases is targeted rather than random and is based on the course of the disease and the patients’ previous treatment. The study drug is administered as an infusion.

Eligible participants include women and men aged 18 and older with advanced lymphoma (classical Hodgkin lymphoma, peripheral T-cell lymphoma, diffuse large B-cell lymphoma, or anaplastic large cell lymphoma) in whom the disease has recurred after prior treatment (recurrence) or no longer responds to standard therapy (refractory). The malignant cells must express the surface protein CD30. Participation is excluded in cases of active central nervous system disease.

Facts 1. Which disease: Classic Hodgkin lymphoma, peripheral T-cell lymphoma, diffuse large B-cell lymphoma, and anaplastic large cell lymphoma. 2. Cancer characteristics: Previously treated, CD30-positive, relapsed/refractory lymphoma. 3. What the study investigates: Safety and dosing of PF-08046044/SGN-35C. 4. Study objective: To assess side effects and tolerability, and to determine the optimal dosage and efficacy. 5. Study duration: Treatment duration up to one year; follow-up period approximately 40 days. 6. Study characteristics: Phase 1 study; open-label; three parts (dose-finding, dose optimization, efficacy evaluation).