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This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients With Advanced Solid Tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: Safety run-in | Experimental | Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol. |
|
| Phase 2: Dose expansion | Experimental | 7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7MW3711 | Drug | 7MW3711 will be administered as IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | AEs are assessed based on NCI CTCAE v6.0. | Up to approximately 2 years |
| Maximum tolerate dose(MTD) | MTD of 7MW3711 | Up to approximately 2 years |
| Recommended Expansion Dose (RED) | RED of 7MW3711 | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) | AUC of 7MW3711 | Up to approximately 2 years |
| Maximum concentration (Cmax) | Cmax of 7MW3711 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Lu, Doctor | Contact | 021-22200000 | 3121 | shun_lu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200043 | China |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| JS207 | Drug | JS207 will be administered as IV infusion. |
|
| Cisplatin | Drug | Cisplatin will be administered as IV infusion. |
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| Carboplatin | Drug | Carboplatin will be administered as IV infusion. |
|
| Up to approximately 2 years |
| Plasma clearance (CL) | CL of 7MW3711 | Up to approximately 2 years |
| Half-life (t1/2) | t1/2 of 7MW3711 | Up to approximately 2 years |
| Time to peak drug concentration (Tmax) | Tmax of 7MW3711 | Up to approximately 2 years |
| Investigator-assessed progression-free survival (PFS) | PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Overall survival (OS) | OS defined as the time interval from the first study drug administration to death due to any cause. | Up to approximately 2 years |
| Investigator-assessed disease control rate (DCR) | DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD). | Up to approximately 2 years |
| Immunogenicity | Incidence and rates of ADA | Up to approximately 2 years |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |