B-cell Malignancy
Conditions
Brief summary
The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.
Interventions
DRUGHRS-1635
HRS-1635
Sponsors
Chengdu Suncadia Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 3. Expected survival time ≥ 12 weeks; 4. Histologically or cytologically confirmed relapsed/refractory B-cell malignant tumor; 5. Females of childbearing potential and male participants whose partners are females of childbearing potential must agree to adopt adequate and effective contraceptive measures during the study period. Female participants must not be breastfeeding; 6. Participants voluntarily enroll in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up procedures.
Exclusion criteria
1. Tumor infiltration of the central nervous system; 2. A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug; 3. A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 4. Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test; 5. Positive for hepatitis C virus antibody (HCV-Ab) at screening with evidence of viral replication confirmed by HCV-RNA test; 6. Positive for human immunodeficiency virus (HIV) antigen/antibody test at screening; 7. History of major surgery or severe trauma within 28 days prior to the first administration of the study drug; 8. Presence of severe cardiovascular disease.; 9. Persistent alcohol or drug abuse; 10. Inability to take oral medication, or presence of severe gastrointestinal dysfunctional diseases, or history of surgery with severe impact on gastrointestinal function. 11. Pregnant or lactating females. 12. Concurrent participation in other interventional clinical trials, or an interval of less than 1 month between the signing date of the informed consent form and the last administration of the study drug in the previous clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events. | approximately 2 year |
| DLT（Dose-limiting toxicity） | approximately 23 days |
Secondary
| Measure | Time frame |
|---|---|
| Peak Concentration (Cmax) | 15 weeks after treatment initiation |
| Area Under the Curve (AUC0-t, AUC0-inf) | 15 weeks after treatment initiation |
| Half-life (t1/2) | 15 weeks after treatment initiation |
| Apparent Clearance (CL/F) | 15 weeks after treatment initiation |
| Apparent Volume of Distribution (Vz/F) | 15 weeks after treatment initiation. |
| Relative bioavaliability of HRS-1635 in the fed versus fasted state. | 48 hours post-dose |
| Objective Response Rate (ORR) | approximately 2 year |
| Time to Response (TTR) | approximately 2 year |
| Duration of Response (DoR) | approximately 2 year |
| Progression-Free Survival (PFS) | approximately 2 year |
| Overall Survival (OS) | approximately 2 year |
| Time to Peak Concentration (Tmax) | 15 weeks after treatment initiation |
Countries
China
Contacts
CONTACTBin Hu
Outcome results
None listed