Title
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and with Cetuximab, in Patients with Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)

Description
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)

Objective
Primary:
-To evaluate the anti-tumor efficacy of 900 mg VS-7375 monotherapy or 900 mg VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with metastatic KRAS G12D mutated PDAC.
-characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.

Secondary:
-To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.
-To continue to evaluate the PK of VS-7375 in participants with KRAS G12D-mutated PDAC.

Treatment 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

Key Eligibility 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

Applicable Disease Sites
Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital