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
Not provided
The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-010 | Experimental | GLS-010 therapy |
|
| chemotherapy | Active Comparator | chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-010 | Drug | Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014 | Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason | Up to 2 years |
| Objective Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) | Up to 2 years | From the time of signed informed consent through 90 days after the last dose of GLS-010 |
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ting lu | Contact | 0086-10-88196391 | luting_1010@163.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chemotherapy of Investigator's choice | Drug | Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD |
|
ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.
| Up to 2 years |
| Disease Control Rate (DCR) | DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014. | Up to 2 years |
| Duration of Response (DoR) | Up to 2 years | DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first |
| Time to Response (TTR) | Up to 2 years | TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719848 | zimberelimab |
Not provided
Not provided
Not provided