| Eligibility |
Inclusion Criteria:
- All Subjects
1. Able to provide written and signed informed consent and any locally required
authorization obtained from the subject/legal representative, which must be
obtained prior to performing any protocol related procedures.
2. Men or women aged =18 years and =75 at the time of study entry.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or
1.
4. Life expectancy =12 weeks.
5. Willing and able to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures as specified in the protocol.
6. Subjects must provide the tumor tissue samples after the diagnosis of solid tumor
or lymphoma.
7. Adequate organ function.
8. Subjects with Solid Tumors:Subjects must have a histologically or cytologically
confirmed advanced solid tumor that is refractory or relapsed to the current
standard therapies, or for which no effective standard therapy is available.
Subject must have at least 1 measurable lesion according to RECIST v1.1.
9. Subjects with Lymphomas:Subjects must have histologically confirmed non-Hodgkin
lymphoma(NHL), which may include transformed lymphoma, relapsed or refractory to
autologous hematopoietic stem cell transplantation, or at least 2 lines of prior
chemotherapy. Subjects must have disease that is measurable or assessable for
response as per Lugano Classification 2014.
Exclusion Criteria:
- All Subjects
1. Concurrent enrollment in another clinical study, unless it is an observational
clinical study or the follow up period of an interventional study.
2. Prior malignancy active within the previous 3 years except for the tumor for
which a subject is enrolled in the study, and locally curable cancers that have
been apparently cured.
3. Receipt: The last cycle of anticancer therapy within 3 weeks prior to the first
dose of investigational product; Anticancer small molecule targeted agent,
palliative local treatment for non-target lesions, non-specific immunomodulatory
therapy within 2 weeks prior to the first dose of investigational product;
Chinese medicines with anti-tumor indications within 1 week prior to the first
dose of investigational product; Any major surgery within 4 weeks; RBC infusion
within 3 months.
4. Metastasis or infiltration of brainstem and meninges;Metastasis or compression of
the spinal cord; Active brain/central nervous system (CNS) metastases.
5. Subjects with clinical symptoms or repeated drainage of pleural effusion,
pericardial effusion or ascites.
6. Cancer invasion of important surrounding organs or risk of esophageal tracheal
fistula or esophageal pleural fistula.
7. Known history of testing positive for human immunodeficiency virus (HIV) or known
active acquired immunodeficiency syndrome.
8. Known active hepatitis B or C infections (known positive HBsAg result or positive
HCV antibody with detectable HCV ribonucleic acid [RNA] results).
9. Active or prior documented autoimmune disease that may relapse.
10. History of interstitial lung disease or noninfectious pneumonitis, except for
those induced by radiation therapies.
11. History of hemolytic anemia of any cause within 3 months prior to the first dose
of investigational product.
12. History of defects in RBC production, or hemoglobin production or
metabolism.History of hemophagocytic lymphohistiocytosis.
13. Previous or current gastrointestinal perforation, surgical incision, wound
healing complications and bleeding events.
14. Patients with clinically significant cardio-cerebrovascular disease.
15. Unresolved toxicities from prior anticancer therapy, defined as having not
resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the eligibility
criteria with the exception of toxicities not considered a safety risk.
16. Subjects with a condition requiring systemic treatment with either
corticosteroids or other immunosuppressive medications within 14 days prior to
the first dose of investigational product.
17. Subjects with prior use of anti-PD-1, anti-PD-L1, anti-CTLA-4, or any other
immuno-oncology agents, receipt of the following treatments or procedures: Use of
immunotherapy or IO drug within 21 days prior to the first dose; Subjects had an
irAE that resulted in permanent discontinuation of previous immunotherapy;
Subjects had a history of grade 3 or higher irAE or cardiac, neurological, or
ocular irAE of any grade at the time of prior immunotherapy; Prior to screening
in this study, all AEs at the time of previous immunotherapy had not been
completely remission or remission to grade 1; Subjects need to use other
immunosuppressants other than glucocorticoids systematically to treat irAE.
18. History of severe hypersensitivity reactions to other mAbs.
19. History of organ transplantation.
20. Known allergy or reaction to any component of the investigational product
formulation.
21. Receipt any anticancer therapy targeting the CD47/SIRPa signaling axis.
22. Known history of mental illness, alcohol or drug abuse.
23. Existing uncontrolled comorbiditions; Or a mental illness/social condition that
may limit the subject's compliance with study requirements or affect the
subject's ability to provide written informed consent.
24. Other exclusion criteria for subjects with lymphoma:History of HTLV-1
infection.Subjects with primary or secondary central nervous system lymphoma.
Subjects with history of allogeneic hematopoietic stem cell transplantation.
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