Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SHC014748M in patients with relapsed or refractory indolent B-cell hematologic malignancies.
This is a phase I, sequential dose escalation followed by cohort expansion study of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory indolent B-cell hematologic malignancies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHC014748M treatment | Experimental | SHC014748M capsule, 50, 100, 150, 200, 250 mg, QD, 28 days for each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHC014748M | Drug | a selective PI3Kδ inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | 1 month | |
| Time to Peak Plasma Concentration(Tmax) | 1 month | |
| Peak Plasma Concentration (Cmax) | 1 month | |
| Half-life Time(t1/2) | 1 month | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | up to 12 months | |
| Lymph Node Response (LNR) | up to 12 months | |
| Time to Response (TTR) |
Not provided
Inclusion Criteria:
1.18- 75 years of age.
2.Histologically or cytologically confirmed diagnosis of relapsed or refractory indolent B-cell hematologic malignancies, including but not limited to CLL / SLL, FL (grade 1, 2 or 3a), or MZL.
3.Patients have received at least 1 prior regimen (at least 2 cycles).
4.Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
5.Life expectancy ≥ 3 months.
6.Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension as assessed by CT or MRI.
7.Adequate organ function, as defined by the following values: ANC≥1.0×10^9/L; PLT≥50×10^9/L; Hb≥80 g/L; TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; BUN and Cr≤1.5×ULN; LVEF≥50%; QTcF <450 ms for male, QTcF <470 ms for female;
8.Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
9.Subjects did not participate in other clinical trials within 3 months prior to study entry.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Guo | Contact | +86025-81066427 | guoweiyf@sanhome.com | |
| Xiaodan Lyu | Contact | +86025-81066469 | lvxd@sanhome.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianyong Li, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Jie Jin, MD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 12 months |
| Progression-Free Survival (PFS) | up to 12 months |
| Duration of Response (DOR) | up to 12 months |
| The First Affiliated Hospital, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided