Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
ECOG PS=0 or 1
2L+ patients:
Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
Have documented disease progression during or following their most recent prior line of therapy
Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.
1L patients:
Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.
You may not be if
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
Receipt of prior direct RAS inhibitor
Receipt of more than 1 investigational therapy
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
Clareo Health | A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
