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Based on the adjustment of clinical research and development strategy,sponsor decided to terminate the study
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This is an Open label, Phase â… b Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
This is a multi-center, open label, phase 1 study conducted in RR DLBCL patients. The MTD and/or RP2D of study treatment, ATG-010 in combination with ATG-008, will be selected using BOIN design for the dose escalation phase. Additional patients will be enrolled as an expansion cohort after MTD and/or RP2D is determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-010 and ATG-008 | Experimental | ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-010 and ATG-008 | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MTD | Maximum Tolerated Dose | the last patient on study has completed 12 months of follow-up |
| RP2D | Recommended Phase 2 Dose | the last patient on study has completed 12 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | the last patient on study has completed 12 months of follow-up |
| PFS | Progression Free Survival | the last patient on study has completed 12 months of follow-up |
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Inclusion Criteria:
Age ≥18 years old.
ECOG Performance score of ≤2.
Estimated life expectancy of >3 months.
Previously treated, pathologically confirmed DLBCL
Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL.
Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Yu | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China | ||
| Sun Yat-sen University Cancer Center |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| DOR | Duration of Response | the last patient on study has completed 12 months of follow-up |
| OS | Overall Survival | the last patient on study has completed 12 months of follow-up |
| TTR | Time To Response | the last patient on study has completed 12 months of follow-up |
| TTP | Time To Progression | the last patient on study has completed 12 months of follow-up |
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410029 | China |
| The first Affiliated Hospital of China medical University | Shenyang | Liaoning | 110001 | China |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |