NCT06892054

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.

Detailed description

This is a phase 2, multicenter and open-label study of first-line chemotherapy (gemcitabine combined with nab-paclitaxel \[gem/nab-P\] or modified FOLFIRINOX \[mFOLFIRINOX\]) in combination with sotorasib for patients with advance pancreatic cancer harboring KRAS p.G12C mutation.The study will be conducted at approximately 25 sites distributed in two countries (Spain and France). The study will consist of a screening period, a treatment period, a safety follow-up (SFU) and long-term follow-up (LTFU) period. A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX) in combination with sotorasib 960 mg daily (QD). An interim safety analysis will be conducted by an independent data monitoring committee (DMC) DMC after the first 3 evaluable patients treated with sotorasib combined with gem/nab-P and an additional interim safety analysis with the first 3 evaluable patients treated with sotorasib combined with mFOLFIRINOX have been treated for at least 1 month, respectively. Patients may discontinue treatment because of disease progression, intolerance of treatment leading to treatment discontinuation, initiation of another anticancer therapy, or withdrawal of consent.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)	A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX) in combination with sotorasib 960 mg daily (QD). The treatment with gem/nab-P and mFOLFIRINOX should be managed as per clinical practice.

Timeline

• Start date: 2025-06-30
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

25 sites across 2 countries: France, Spain