NCT07066098RecruitingPhase 3
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 · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- 17 Jul 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07066098
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 201
- From 17 Jul 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with topoisomerase inhibitor-based ADC.
- 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.
- 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) .
Other illness
- History of other primary malignancies, except cured or low-risk of recurrence.
Other
- Participation in another interventional study, except observational or post-intervention follow-up.
- Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
Who the study is looking for
- Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
- Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
- Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
- ECOG PS score of 0 or 2.
- Adequate bone marrow and organ function
- Confirmed as CLDN18.2 positive.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.