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This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.
This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. It is planned to enroll 201 participants, and participants will be randomized to receive IBI343 plus BSC or placebo plus BSC in a 2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | IBI343 |
|
| Control Arm | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI343 | Drug | Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | Overall survival (OS) is defined as the time from randomization to death from any cause. | approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival(PFS) | Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause. | approximately 24 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Penglei Zheng | Contact | 86-512-69566088 | penglei.zheng@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
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| Placebo | Drug | Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle |
|
ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) per RECIST v1.1.
| approximately 24 months |
| disease control rate (DCR) | DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) per RECIST v1.1 criteria. | approximately 24 months |
| duration of response (DoR) | DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR per RECIST v1.1 criteria. | approximately 24 months |
| time to response (TTR) | TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria. | approximately 24 months |
| Adverse Event | Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0. | approximately 24 months |
| Area under the plasma concentration versus time curve (AUC) | area under the curve (AUC) of single and multiple doses of IBI343 | approximately 24 months |
| immunogenicity | anti-drug antibody and/or neutralizing antibody | approximately 24 months |
| maximum concentration (Cmax) | maximum concentration (Cmax) of single and multiple doses of IBI343 | approximately 24 months |
| time to maximum concentration (Tmax) | time to maximum concentration (Tmax) of single and multiple doses of IBI343 | approximately 24 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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