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This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6090 + Pemetrexed + Platinum | Experimental | SYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC). |
|
| SYS6090 + Paclitaxel + Platinum | Experimental | SYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC). |
|
| SYS6090 + Docetaxel | Experimental | SYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC). |
|
| SYS6090 + Pemetrexed + Bevacizumab + Platinum | Experimental | SYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). |
|
| SYS6090 + SYS6010 (nsqNSCLC) | Experimental | SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6090 + pemetrexed + platinum-based chemotherapy | Drug | In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) (Phase Ib) | To evaluate the safety of SYS6090 in participants. | Approximately 21 days. |
| Adverse Events (AEs) (Phase Ib) | To evaluate the safety of SYS6090 combination therapy in participants. | Up to 90 days after the last administration |
| Objective response rate (ORR) (Phase II) | ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response. | Through out the study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of SYS6090 (and SYS6010 if applicable) | To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable). | Through out the study (up to 2 years) |
| AUC0-t of SYS6090 (and SYS6010 if applicable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 031169085587 | ctr-contact@cspc.cn |
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|
| SYS6090 + SYS6010 (NSCLC) | Experimental | SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC). |
|
| SYS6090 + Etoposide + Platinum | Experimental | SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC). |
|
| SYS6090 + Chemo/Other Anticancer Therapy | Experimental | SYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer. |
|
| SYS6090 + paclitaxel + platinum-based chemotherapy | Drug | In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy. |
|
| SYS6090 + docetaxel | Drug | In this group, participants will receive SYS6090 in combination with docetaxel. |
|
| SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy | Drug | In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy |
|
| SYS6090 + SYS6010 | Drug | In this group, participants will receive SYS6090 and SYS6010. |
|
| SYS6090 + etoposide + platinum-based chemotherapy | Drug | In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy. |
|
| SYS6090 + chemotherapy or other anticancer therapy | Drug | In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies. |
|
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicableļ¼
| Through out the study (up to 2 years) |
| Clearance (CL) of SYS6090 (and SYS6010 if applicable) | To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable) | Through out the study (up to 2 years) |
| Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS) | Evaluation of other efficacy endpoints of SYS6090 combination therapy in participants with advanced lung cancer, assessed by the investigator according to RECIST v1.1, including duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). | Through out the study (up to 2 years) |
| Adverse Events (AEs) (Phase II) | To evaluate the safety of SYS6090 combination therapy in participants | Through out the study (up to 2 years) |
| Correlation between Biomarker Levels and Preliminary Efficacy | The Correlation between Baseline PD-L1 Expression and Antitumor Activity | Through out the study (up to 2 years) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D017671 | Platinum Compounds |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000068258 | Bevacizumab |
| D005047 | Etoposide |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D007287 | Inorganic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
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