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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial (RP2D) will be determined based on the safety, tolerability, pharmacokinetics and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: esophogeal squamous carcinoma | Experimental | In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan |
|
| Cohort 2: gastric cancer | Experimental | In Cohort 2, patients will be treated with JS015 in combination with paclitaxel |
|
| Cohort 3: gastric cancer | Experimental | In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX |
|
| Cohort 4: colorectal cancer | Experimental | In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI |
|
| Cohort 5: pancreatic cancer | Experimental | In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS015 | Biological | JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of dose-limiting toxicity (DLT) | incidence and severity of DLT | 2 Years |
| incidence of adverse event(AE) | adverse events (AE) | 2 Years |
| Recommended dose for phase II trial RP2D | Recommended dose for phase II trial | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | The highest plasma drug concentration that can be achieved after medication | 2 years |
| time to peak concentration(Tmax) | The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration |
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Inclusion Criteria:
1. Patients who meet the following criteria for each indication cohort:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiangnian Liu, PM | Contact | +86 18733176288 | jiangnian_liu@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D017239 | Paclitaxel |
| D000077146 | Irinotecan |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Toripalimab | Biological | Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle. |
|
| Paclitaxel | Biological | Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle. |
|
| Irinotecan | Drug | Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle. |
|
| Capecitabine | Drug | Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle. |
|
| Oxaliplatin | Drug | Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle. |
|
| Bevacizumab | Biological | Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy. |
|
| Fluorouracil | Drug | Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle. |
|
| Leucovorin | Drug | Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle. |
|
| Gemcitabine | Drug | Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle. |
|
| Albumin-Bound Paclitaxel | Drug | Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle. |
|
| 2 years |
| elimination half life(t1/2) | The time it takes for the concentration of the drug in the plasma to be reduced by 50% | 2 years |
| immunogenicity | Incidence of Anti-Drug Antibody (ADA) | 2 years |
| Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) | 2 years |
| Progression free survival (PFS) | The time from first dose to Disease progression or death | 2 years |
| overall survival (OS) | The time from first dose to death from any cause | 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| 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 |
| 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 |
| D000418 | Albumins |