SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
Chinese PLA General Hospital
100 participants
Jun 14, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 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 Criteria7
- 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.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Interventions
SHR2554: 350mg/day, PO, twice a day. SHR1701: recommended dose from phase I trial, IV, over 30 minutes.
Phase I: 30-150 mg/kg, IV over 30 minutes. Phase II: recommended dose from phase I trial, IV over 30 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05896046