Phase
Condition
Digestive System Neoplasms
Pancreatitis
Pancreatic Cancer
Treatment
IBI343
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the written informed consent form (ICF) and be willing and able to comply withthe visits and related procedures stipulated in the plan.
Histologically confirmed unresectable locally advanced, or metastatic pancreaticcancer.
Have received and progression after at least two systemic therapies(must including afluorouracil-based and a gemcitabine-based therapy).
ECOG PS score of 0 or 2.
Adequate bone marrow and organ function
Confirmed as CLDN18.2 positive.
Exclusion
Exclusion Criteria:
Participation in another interventional study, except observational orpost-intervention follow-up.
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 affectresponse assessment is allowed) .
Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed withspecific criteria.
History of other primary malignancies, except cured or low-risk of recurrence.
Study Design
Study Description
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 201321
ChinaActive - Recruiting

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