Phase 3 Study of Investigator Choice of Chemotherapy with or without Zoldonrasib as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma

Brief summary (registry, in English)

To compare the efficacy of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP)

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 281
• 64 sites in 12 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed pancreatic adenocarcinoma that has spread (metastatic) and carries a KRAS G12D mutation. It tests chemotherapy with zoldonrasib or with placebo.

Age

18 years or older (or the legal age of consent)

Sex

All sexes can join.

Disease stage

Metastatic pancreatic adenocarcinoma, newly diagnosed within 6 weeks or less before screening. At least one lesion that can be measured (RECIST 1.1). ECOG performance status of 0 or 1.

Earlier treatment

No earlier systemic therapy for unresectable locally advanced or metastatic pancreatic adenocarcinoma. No earlier RAS-targeted therapy (including KRAS inhibitors) or MAPK pathway targeted drugs.

Biomarker or test result

A KRAS G12D mutation confirmed by a validated test.

Main reasons for not taking part

• Other known driver gene changes that have approved targeted treatment (for example BRAF V600E, MSI-high/dMMR, NTRK fusions)
• Pancreatic cancers that are not adenocarcinoma (for example neuroendocrine tumors, acinar cell carcinoma)
• Brain or CNS spread that is untreated or causes symptoms, or leptomeningeal disease
• Active infections that are not controlled, including hepatitis B, hepatitis C or HIV
• Major surgery within 28 days before randomization

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (64)

Sites in registry order. Save your city in your profile to sort them by distance.

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