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OncoMatch/Clinical Trials/NCT07066098

A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

Is NCT07066098 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies IBI343 for pancreatic cancer.

Phase 3RecruitingInnovent Biologics (Suzhou) Co. Ltd.NCT07066098Data as of May 2026

Treatment: IBI343This 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Required: CLDN18 positive

Confirmed as CLDN18.2 positive.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Must have received: fluorouracil-based therapy

Have received and progression after at least two systemic therapies (must including a fluorouracil-based and a gemcitabine-based therapy).

Must have received: gemcitabine-based therapy

Have received and progression after at least two systemic therapies (must including a fluorouracil-based and a gemcitabine-based therapy).

Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate

Prior treatment with topoisomerase inhibitor-based ADC.

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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