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This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | Patients will receive Rocbrutinib at 150 mg once daily in combination with R-GemOx |
|
| Dose Level 2 | Experimental | Patients will receive Rocbrutinib at 200 mg once daily in combination with R-GemOx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocbrutinib | Drug | Patients will receive Rocbrutinib until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Dose-Limiting Toxicities | At the end of Cycle 1 (the length of cycle 1 is 21 days) |
| MTD | Maximum Tolerated Dose | At the end of Cycle 1 (the length of cycle 1 is 21 days) |
| Adverse events as assessed by CTCAE v5.0 | From the first administration to 28 days after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | Up to approximately two years |
| TTR | Time to Response | Up to approximately two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | 086-20-87343355 | caiqq@sysucc.org.cn | |
| Rong Tao | Contact | 086-210-64175590 | hkutao@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510050 | China | ||
| Fudan University Shanghai Cancer Center |
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| R-GemOx | Drug | Patients will receive 6 cycles every 21 days of R-GemOx. Rituximab 375mg/m2 i.v. on day 1 of every cycle. GemOx (gemcitabine 1000mg/m2 plus oxaliplatin 100mg/m2) i.v. on day 2 of each cycle. |
|
| DoR | Duration of Response | Up to approximately two years |
| PFS | Progression-free Survival | Up to approximately two years |
| OS | Overall Survival | Up to approximately two years |
| Cmax | Maximum Plasma Concentration | From 1 hour prior to administration to 24 hours post-dose |
| Tmax | Time to Maximum Plasma Concentration | From 1 hour prior to administration to 24 hours post-dose |
| AUC0-t | Area Under the Plasma Concentration-Time Curve from Time Zero to Time t | From 1 hour prior to administration to 24 hours post-dose |
| t1/2 | Half-life | From 1 hour prior to administration to 24 hours post-dose |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |