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This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7058 + SHR-1316 | Experimental |
| |
| HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy | Experimental |
| |
| HRS-7058 + Cetuximab | Experimental |
| |
| HRS-7058 + SHR-1826 | Experimental |
| |
| HRS-7058 + SHR-1826 + SHR-1316 | Experimental |
| |
| HRS-7058 + SHR-A1202 | Experimental |
| |
| HRS-7058 + BP102 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7058 + SHR-1316 | Drug | HRS-7058 + SHR-1316 |
| |
| HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months | |
| Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months] | |
| Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months] | |
| Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months | |
| Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sida Zhu | Contact | +0518-81220121 | sida.zhu.sz15@hengrui.com | |
| Linan Wang | Contact | +0518-81220121 | linan.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| HRS-7058 + SHR-9839 | Experimental |
|
| HRS-7058 +SHR-A2102 +SHR-1316 | Experimental |
|
| HRS-7058 +SHR-9839(sc)+SHR-1316 | Experimental |
|
| HRS-7058 +SHR-1316 +BP102 | Experimental |
|
| HRS-7058 +SHR-A2102 +BP102 | Experimental |
|
| HRS-7058 +SHR-A2102 +SHR-1316 +BP102 | Experimental |
|
| Drug |
HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy |
|
| HRS-7058 + Cetuximab | Drug | HRS-7058 + Cetuximab |
|
| HRS-7058 + SHR-1826 | Drug | HRS-7058 + SHR-1826 |
|
| HRS-7058 + SHR-1826 + SHR-1316 | Drug | HRS-7058 + SHR-1826 + SHR-1316 |
|
| HRS-7058 + SHR-A1202 | Drug | HRS-7058 + SHR-A1202 |
|
| HRS-7058 + BP102 | Drug | HRS-7058 + BP102 |
|
| HRS-7058 + SHR-9839 | Drug | HRS-7058 + SHR-9839 |
|
| HRS-7058 +SHR-A2102 +SHR-1316 | Drug | HRS-7058 +SHR-A2102 +SHR-1316 |
|
| HRS-7058 +SHR-9839(sc)+SHR-1316 | Drug | HRS-7058 +SHR-9839(sc)+SHR-1316 |
|
| HRS-7058 +SHR-1316 +BP102 | Drug | HRS-7058 +SHR-1316 +BP102 |
|
| HRS-7058 +SHR-A2102 +BP102 | Drug | HRS-7058 +SHR-A2102 +BP102 |
|
| HRS-7058 +SHR-A2102 +SHR-1316 +BP102 | Drug | HRS-7058 +SHR-A2102 +SHR-1316 +BP102 |
|
| From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: overall survival (OS) (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Safety endpoints: adverse events (AE)(Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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