A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)
Study Identifier:
VS-7375-202
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Metastatic Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: 2L-4L with brain metastasis
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Drug: 2L-4L VS-7375 dose
Drug: Drug: VS-7375
Drug: Taken by mouth
Drug: EXPERIMENTAL: VS-7375 Monotherapy 2L/3L
Drug: 2L/3L VS-7375 dose
Drug: EXPERIMENTAL: VS-7375 Monotherapy 2L/3L Preferred Dose
Drug: 2L/3L Preferred VS-7375 dose
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- * Histopathology confirmed unresectable locally advanced or metastatic NSCLC
- * 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
- * Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.
- * Have documented disease progression during or following their most recent prior line of therapy.
- Patients with 2L/3L on stable or preferred dose:
- * Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
- Patients with 2L-4L with brain metastases:
- * Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
- * Have asymptomatic and untreated brain metastases
- * At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm. Parts A and B- Prior treatment with platinum-based chemo and ICI. At least 1 and no more than 2 prior systemic lines of therapy
- Part C: Received at least 1 and no more than 3 prior systemic lines of therapy
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
- * 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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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Metastatic Cancer
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Salwan Al Mutar
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Metastatic Cancer
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Metastatic Cancer