Clinical trial · Interventional
A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)
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>=2 Prior Lines of Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI343 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- IBI343
- interventionNames
- Drug: IBI343
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- overall survival(OS)
- timeFrame
- approximately 24 months
- description
- Overall survival (OS) is defined as the time from randomization to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan. 2. Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer. 3. Have received and progression after at least two systemic therapies(must including a fluorouracil-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 Criteria: 1. Participation in another interventional study, except observational or post-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 affect response assessment is allowed) . 5. Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria. 6. History of other primary malignancies, except cured or low-risk of recurrence.
References
Publications (0)
Data not yet available