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

Last updated: August 14, 2025
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Pancreatitis

Pancreatic Cancer

Treatment

IBI343

Placebo

Clinical Study ID

NCT07066098
CIBI343B302
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the written informed consent form (ICF) and be willing and able to comply withthe visits and related procedures stipulated in the plan.

  2. Histologically confirmed unresectable locally advanced, or metastatic pancreaticcancer.

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

  4. ECOG PS score of 0 or 2.

  5. Adequate bone marrow and organ function

  6. Confirmed as CLDN18.2 positive.

Exclusion

Exclusion Criteria:

  1. Participation in another interventional study, except observational orpost-intervention follow-up.

  2. Prior treatment with topoisomerase inhibitor-based ADC.

  3. Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.

  4. Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affectresponse assessment is allowed) .

  5. Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed withspecific criteria.

  6. History of other primary malignancies, except cured or low-risk of recurrence.

Study Design

Total Participants: 201
Treatment Group(s): 2
Primary Treatment: IBI343
Phase: 3
Study Start date:
August 04, 2025
Estimated Completion Date:
June 30, 2028

Study Description

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.

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 201321
    China

    Active - Recruiting

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