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This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1826 | Drug | SHR-1826 |
| |
| SHR-4642 |
| Measure | Description | Time Frame |
|---|---|---|
| RP2D (Phase 1) | Screening up to study completion, an average of 1 year. | |
| AE (Phase 1) | Screening up to study completion, an average of 1 year. | |
| Objective response rate (ORR) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) (Phase 1) | Screening up to study completion, an average of 1 year. | |
| Disease control rate (DCR) (Phase 1) | Screening up to study completion, an average of 1 year. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongfu Mao, MD | Contact | +86-021-61053363 | rongfu.mao@hengrui.com | |
| Hao Shen, BS | Contact | +86-021-61053363 | hao.shen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen university cancer center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Drug |
SHR-4642 |
|
| SHR-9839 | Drug | SHR-9839 |
|
| SHR-8068 | Drug | SHR-8068 |
|
| Bevacizumab Injection | Drug | Bevacizumab Injection |
|
| Fluorouracil Injection | Drug | Fluorouracil Injection |
|
| Calcium Folinate Injection | Drug | Calcium Folinate Injection |
|
| Adebrelimab Injection | Drug | Adebrelimab Injection |
|
| Capecitabine tablets | Drug | Capecitabine tablets, oral. |
|
| Duration of response (DoR) (Phase 1) |
| Screening up to study completion, an average of 1 year. |
| Progression-free survival (PFS) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Overall survival (OS) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Drug Resistant Antibody (ADA) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Blood concentration of SHR-1826 (Phase 1) | Screening up to study completion, an average of 1 year. |
| Blood concentration of free toxin SHR169265 (Phase 1) | Screening up to study completion, an average of 1 year. |
| Disease control rate (DCR) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Duration of response (DoR) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Progression-free survival (PFS) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Overall survival (OS) (Phase 2) | Screening up to study completion, an average of 1 year. |
| AE (Phase 2) | Screening up to study completion, an average of 1 year. |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000069287 | Capecitabine |
| 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 |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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