A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT05354362 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-03-17
Summary
This is an Open label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Conditions
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
Interventions
- COMBINATION_PRODUCT
-
ATG-010 and ATG-008
Patients enrolled will receive consecutive daily treatment at assigned dose level. The starting dose of ATG-010 at the dose escalation phase will be 60 mg QW, which could be escalated to 80 mg QW, 100 mg QW, 60 mg BIW. In case 60 mg QW of ATG-010 with any dose of ATG-008 is NOT tolerable, 40 mg QW ATG-010 could be explored. The starting dose of ATG-008 will be 15 mg QD, which could be escalated to 20 mg QD, with maximum of 30 mg QD. SRC will be consulted before each dose escalation starts.
Sponsors & Collaborators
-
Antengene Corporation
lead INDUSTRY
Principal Investigators
-
Yang Yu · Medical Monitor
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-02
- Primary Completion
- 2023-02-06
- Completion
- 2023-02-08
Countries
- China
Study Locations
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