Overview
Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies
Status:
Unknown status
Unknown status
Trial end date:
2020-05-01
2020-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1 antibody alone or in combination with low-dose decitabine in patients with relapsed or refractory malignancies, including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Han weidongTreatments:
Antibodies
Azacitidine
Decitabine
Immunoglobulins
Criteria
Inclusion Criteria:1. Subjects must have histological confirmation of relapsed or refractory
malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal
cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or
renal-cell cancer or pancreatic cancer or bile duct cancer.
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by
lymphoma response criteria; with solid tumors must have at least one measureable
lesion >1 cm per RECIST1.1.
6. Subjects must have received at least two prior chemotherapy regimen, 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.
7. Subjects must have adequate bone marrow, live, renal, lung and heart functions.
1. Absolute neutrophil count greater than or equal to 1,000/μL.
2. Platelet count greater than or equal to 70,000/µL.
3. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
4. Serum creatinine less than or equal to 1.5 x ULN.
5. Alanine aminotransferase [ALT or SGPT] and aspartate aminotransferase [AST or
SGOT] less than or equal to 2.5 x ULN.
Exclusion Criteria:
1. Subjects with any autoimmune disease or history of syndrome that requires
corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary and intestinal
infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1
month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness.