Dysautonomia International

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

Purpose

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)
G12D Mutated KRAS

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Histopathology confirmed PDAC - Measurable disease per RECIST 1.1 - Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) - ECOG PS=0 or 1 Adequate organ function VS-7375 + cetuximab (2L PDAC) : -Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months VS-7375 + cetuximab (1L PDAC) : -Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease

Exclusion Criteria

Have any other documented co-existing common RAS mutation(s) - Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter - Major surgery within 4 weeks of first treatment dose - Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose - History of drug-induced Interstitial Lung Disease - Receipt of prior direct RAS inhibitor - Untreated or symptomatic CNS metastasis - Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter - Receipt of PPI or H2 blocker within 5 days - Inability to swallow oral medication - Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)