Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT06892054
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 8, 2025
Status verified
Apr 2026
Primary completion
Aug 8, 2030
Completion
Aug 8, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: First-line chemotherapy (gem/nab-P or FOLFIRINOX) combined with sotorasib
    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).mFOLFIRINOX is recommended for patients with ECOG PS of 0 to 1, favourable comorbidity profile, patient preference and a support system for aggressive medical therapy, and access to chemotherapy port and infusion pump management services. Gem/nab-P is recommended for patients with ECOG PS of 0 to 1, a relatively favourable comorbidity profile, and patient preference and a support system for relatively aggressive medical therapy. Gem/nab-P is therefore the preferred first line treatment for patients expected to be intolerant to mFOLFIRINOX.

Primary Outcome Measure

To evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation. [ Time Frame: 60 months ]

Central Contacts

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