A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 3RecruitingNCT06238843

Innovent Biologics (Suzhou) Co. Ltd.450 enrolled

Overview

This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）

Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles. Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures. 2. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC). 3. Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy. 4. Has histopathologically confirmed CLDN18.2-positive disease. 5. Is a man or woman of 18 years of age or older at the time of signing the ICF. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Exclusion Criteria: 1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease. 2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3. Has a history of treatment with topoisomerase inhibitorbased 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 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. 5. Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).

Locations (22)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Shikoku Cancer Center

Matsuyama, Ehime, Japan

RECRUITING

Gunma Prefectural Cancer Center

Ota-Shi, Gunma, Japan

RECRUITING

Kure Medical Center And Chugoku Cancer Center

Kure, Hirosima [Hiroshima], Japan

RECRUITING

Teine Keijinkai Hospital

Sapporo, Hokkaido, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Hukuoka [Fukuoka], Japan

RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, Japan

RECRUITING

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

RECRUITING

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

RECRUITING

...and 12 more locations

Outcomes

Primary Outcomes

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.

Time frame: within approximately 20 months

overall survival(OS)

Overall survival (OS) is defined as the time from randomization to death from any cause.

Time frame: within approximately 26 months

Secondary Outcomes

Objective response rate (ORR)

ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1.

Time frame: within approximately 20 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) as determined by the IRRC per RECIST v1.1 criteria.

Time frame: within approximately 20 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 as assessed by IRRC per RECIST v1.1 criteria.

Time frame: within approximately 20 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.

Time frame: within approximately 20 months

area under the curve (AUC)

Area under the curve (AUC) is defined as the area under the plasma concentration versus time curve.

Time frame: within approximately 20 months

maximum concentration (Cmax)

Cmax is the highest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.

Time frame: within approximately 20 months

time to maximum concentration(Tmax)

The time it takes for a drug to reach the maximum concentration (Cmax) after administration of the drug

Time frame: within approximately 20 months

trough concentration (Ctrough)

Ctrough is the lowest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.

Time frame: within approximately 20 months

clearance (CL)

The clearance is defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time.

Time frame: within approximately 20 months

volume of distribution (V)

Volume of distribution (Vd) is defined as the arrangement or rate of incidence of a drug in the body in relation to the measured plasma concentration.

Time frame: within approximately 20 months

Incidence of anti-drug antibody (ADA)

Incidence of anti-drug antibody (ADA) is defined as the sum of both treatmentinduced (post-baseline ADA-positive only) and treatment-boosted ADA.

Time frame: within approximately 20 months

neutralizing antibody (NAb)

Neutralizing antibodies (NAb) are a subset of binding ADA that bind to the drug and inhibit its pharmacological function by preventing target binding.

Time frame: within approximately 20 months

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

Overview

Conditions

Interventions

Eligibility

Locations (22)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts