Brief Summary
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 in patients with advancedat a late stage, far along hematological and solid tumors.
Intervention / Treatment
- Drug: CS5001
Inclusion Criteria:
- For solid tumor patients of dosethe amount of medication taken escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.
- For Lymphomacancers of the lymphatic system patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.
- For dose expansion, pathologically confirmed Mantle Cell Lymphoma(MCL, following at least two prior lines of systemic therapy including Bruton Tyrosine Kinase inhibitors), Diffuse Large B Cell Lymphoma(DLBCL, following at least two prior lines of systemic therapies), and Triple Negative Breast Cancer(TNBC, following at least 2 lines of systemic therapy for advanced disease) will be enrolled.
- For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.
- Life expectancy > 3 months.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group(ECOG) performance status 0 or 1.
- Have adequate organ function.
- Is willing to provide tumor tissuea group of cells that work together to perform a function and control bloodthe red bodily fluid that transports oxygen and other nutrients around the body sample.
- Female subjects of childbearing potential must have a negative serum pregnancy test.
- Both male and female subjects must be willing to use adequate contraception.