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This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine | Experimental |
| |
| nab-paclitaxel in combination with gemcitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine | Drug | HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first. | From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. | up to 10 months following the date the last patient was randomized |
| disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengquan Gu | Contact | 0518-82342973 | zengquan.gu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| HRS-4642;nab-paclitaxel; gemcitabine | Drug | nab-paclitaxel in combination with gemcitabine |
|
Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.
| up to 10 months following the date the last patient was randomized |
| Duration of response (DoR) | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1. | up to 10 months following the date the last patient was randomized |
| Overall survival (OS) | Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. | From study start until target OS events have occurred (approximately 20 months after last patient enrollment) |
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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