Gastric and gastroesophageal junction adenocarcinoma
Conditions
Interventions
Investigational medical product:IBI343 6 mg/kg(intravenous infusion Day1, Q3W)
Reference product:irinotecan 150 mg/m^2(intravenous infusion Day1 and Day15, Q4W)
paclitaxel 80 mg/m^2(intravenous infus
Sponsors
Liu Shijie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Is able and willing to sign a written Informed Consent Form(ICF)and to comply with protocol-specified visits and related procedures. 2.Is considered an adult(e.g., >- 18 years of age in the US and EU)according to local regulation at the time of signing the informed consent. 3.Has an Eastern Cooperative Oncology Group(ECOG)performance status(PS)of 0or1. 4.Has an expected survival of >-12 weeks. 5.Has adequate bone marrow and organ function, defined as: -Hematology: absolute neutrophil count (ANC) >- 1.5x10^9/L; platelet count >- 100x10^9/L;hemoglobin>-9.0 g/dL. The participant must not have received transfusion of blood products(including red blood cell suspension,apheresis platelets,cryoprecipitate,etc.), erythropoietin (EPO),granulocyte-colony stimulating factor (G-CSF),and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to blood sample collection; -Hepatic function: total bilirubin (TBIL) -- 28 g/L (must not have received human albumin infusion within 7 days prior to blood sample collection); -Renal function:creatinine clearance >- 30 mL/min(using Cockcroft-Gault formula);urine protein
Exclusion criteria
Exclusion criteria: 1.Has HER2-positive(defined as IHC 3+,or IHC 2+and positive by in situ hybridization)disease. HER-2 positive participants who have received anti-HER-2 therapy and tested negative for HER-2 in tissue samples post anti-HER-2 therapy can also be included in the study (Unique for randomized phase 3 portion). 2.Is currently participating in another interventional clinical study,except when the participant is in survival follow-up of another interventional clinical study. 3.Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s). 4.Has received the last dose of an anti-cancer therapy(including traditional Chinese medicine indicated for gastric cancer in the package insert,but excluding herbal prescriptions)within 4weeks or 5 half-lives(whichever is shorter)prior to the first dose of study treatment (drugs with no specific half-life need to washout for 4 weeks). 5.Plans to receive other anti-tumor therapy during the study period(palliative radiotherapy for symptomatic(e.g.,pain)relief that does not affect response assessment is allowed). 6.Has received a strong cytochrome P450 3A4(CYP3A4)inhibitor within 2 weeks or 5 half-lives(whichever is longer)prior to the first dose of study drug. 7.Has received within 4 weeks prior to the first dose of study drug or plans to receive a live vaccine during the study. 8.Toxicities due to previous anti-cancer therapy that have not resolved to grade--3 times in 24 hours). 14.Has a history of gastrointestinal perforation and/or fistula and has not recovered after surgery within 6 months prior to the first dose of study drug. 15.Has symptomatic central nervous system metastasis,and/or spinal compression.Participants with asymptomatic brain metastasis(i.e.no neurological symptoms,no need for glucocorticoid treatment,diameter of each brain metastasis-<1.5 cm)or stable symptoms of treated brain metastasis must meet all of the following criteria to participate in the study:no metastasis in the midbrain,pons,cerebellum,meninges,medulla oblongata or spinal cord;stable clinical status for at least 4 weeks with definitive clinical evidence of no new or enlar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - PFS per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by IRRC Note: PFS will be one of the dual primary endpoints in regions whose regulatory authorities (e.g., China) agree to PFS and OS as dual primary endpoint. - OS. Note:OS will be only one primary efficacy endpoint in regions whose regulatory authorities (e.g., Japan) require OS as single primary endpoint. In these regions, PFS will be a key secondary efficacy endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| According to RECIST v1.1 criteria by IRRC, the following endpoints will be evaluated: - Objective response rate (ORR) - Disease control rate (DCR) - Duration of response (DoR) - Time to response (TTR) European Group for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) score and EORTC Quality of Life Questionnaire - Oesophago-Gastric Module (EORTC QLQ-OG 25) score, and EuroQoL-5-Dimensions questionnaire 5 level (EQ-5D-5L) score. Incidence, severity, and relationship to the study drug of all treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs), etc. Changes in vital signs, electrocardiogram (ECG), laboratory test results and so on before and after study treatment. PK parameters in participants receiving IBI343, including but not limited to: area under the curve (AUC), maximum concentration (Cmax), trough concentration (Ctrough), clearance (CL), volume of distribution (V) and half-life (t1/2). Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) in participants receiving IBI343. The effect of ADA on safety, efficacy, and total antibody PK characteristics, if appropriate. | — |
Countries
China, Japan
Contacts
Public Contactcontact Clinical trial
ICON Clinical Research GK
Outcome results
None listed