IBI343 versus placebo for CLDN18.2-positive advanced pancreatic cancer after at least two prior therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind Phase III trial comparing IBI343 monotherapy plus best supportive care to placebo plus best supportive care in patients with CLDN18.2-positive, locally advanced unresectable or metastatic pancreatic cancer who progressed after at least two systemic therapies. About 201 participants will be enrolled and randomized 2:1 to receive IBI343 or placebo, with treatment and follow-up visits at participating centers. The primary endpoint is overall survival, and patients must have adequate organ function and ECOG performance status within the allowed range. The trial is sponsored by Innovent Biologics and will be conducted at participating oncology centers including Fudan University Shanghai Cancer Center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Penglei Zheng
• Email: penglei.zheng@innoventbio.com
• Phone: 86-512-69566088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.