HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer

Recruiting Phase 3 Interventional Study
KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
588 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial

This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Age 18-75 years old (inclusive) at the time of signing the informed consent form 3. Male or female 4. ECOG score of 0 or 1 5. Expected survival ≥ 12 weeks 6. At least one measurable lesion according to RECIST v1.1 crit…
Contacts

Hongxia Han

+0518-81220121

hongxia.han@hengrui.com

CONTACT