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Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

NCT06892054 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

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 at investigator choice) in combination with sotorasib 960 mg daily (QD). The treatment with gem/nab-P and mFOLFIRINOX should be managed as per clinical practice.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    collaborator OTHER

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2030-08-08
Completion
2030-08-08

Countries

  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892054 on ClinicalTrials.gov