SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma (NCT05896046) | Clinical Trial Compass
RecruitingPhase 1/2
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
China100 participantsStarted 2023-06-14
Plain-language summary
This is an open-label, phase I/II dose escalation and expansion trial. The primary objective of dose escalation phase I study is to evaluate the safety and feasibility of SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary objective of open-label, randomized, phase II study is to assess the antitumor effect of SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory classical Hodgkin Lymphoma.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
✓. 12 to 75 years of age.
✓. ECOG performance of less than 2.
✓. Life expectancy of at least 3 months.
✓. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
✓. Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks.
✓. Subjects must have adequate marrow, live, renal and heart functions.
Exclusion criteria
✕. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
✕. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
✕. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
✕. Prior organ allograft.
✕
What they're measuring
1
Phase I : Adverse events
Timeframe: Up to 90 days after the last dose of study drugs