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The purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KH903 + Paclitaxel | Experimental | IV KH903 4 mg/kg IV paclitaxel 80 mg/m² |
|
| Placebo + Paclitaxel | Active Comparator | IV Placebo IV paclitaxel 80 mg/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH903 + Paclitaxel | Drug | KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Date of randomization until the date of first documented Progression or date of death from any cause, whichever came first | Time from date of randomization until the date of first documented Progression or date of death from any cause, whichever came frist,assessed up to18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR) | Time from date of randomization until the date of first documented CR or PR,assessed up to18 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
INR ≤ 1.5× ULN, APTT ≤ 1.5× ULN. Dipstick proteinuria <2+ or 24 hour proteinuria <1g .
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yi ba, PhD | Contact | 13752157916 | bayi@timuch.com |
| Name | Affiliation | Role |
|---|---|---|
| yi ba, PhD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
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| Placebo + Paclitaxel | Drug | Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle |
|
is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months |
| Time from first documented evidence of CR or PR until the date of first documented progression ,assessed up to18 months |
| Disease Control Rate (DCR) | Percentage of Participants who have achieved CR, PR and SD to study treatment; | Time from date of randomization until the date of first documented Progression,assessed up to18 months |
| AE | Number of Subjects with treatment-related adverse events (AEs)Defined by all | AEs(NCI CTCAE 5.0) collected at each cycle,Assessed up to18 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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