TARGET-D 201: A Phase II Study of VS-7375 in Patients with KRAS G12D-Mutated Metastatic Pancreatic Cancer
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Study Summary
To evaluate VS-7375 at 900 mg QD both as monotherapy and in combination with cetuximab in patients with second-line pancreatic ductal carcinoma (PDAC).
To evaluate VS-7375 and cetuximab in the first-line PDAC setting.
To assess the safety and efficacy of VS-7375 both as a monotherapy and in combination with an EGFR-targeted therapy in patients with advanced pancreatic ductal adenocarcinoma harboring a KRAS-G12D mutation.
to evaluate VS-7375 at 900 mg once daily (QD) both as monotherapy and in combination with full-dose cetuximab in patients with second-line metastatic pancreatic ductal carcinoma.
Study also evaluating VS-7375 900 mg and cetuximab in the first-line mPDAC setting, representing a potential chemotherapy-free frontline regimen
To evaluate both the monotherapy and in combination with full-dose cetuximab in patients with second-line metastatic PDAC.
The study also evaluates the combination with cetuximab in the first-line PDAC setting.
- Part A & B: 2L KRAS G12D-mutated PDAC
- Part C: 1L KRAS G12D-mutated PDAC
- * 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
- 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
Clinical Study Information for Healthcare Providers
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