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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526472-23-00

Enrollment

Registered

2026-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

Confirmed ORR by BICR per RECIST v1.1 (supported by DoR, as described below). Part C only: Intracranial ORR by mRECIST v1.1 by BICR., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, dose interruptions/reductions, and discontinuations.

Detailed description

All Parts: Confirmed ORR by Investigator-assessed DoR, BOR, DCR, PFS per RECIST v1.1, and OS. Unless otherwise specified, all response assessment‑based endpoints will be analyzed using BICR (primary) and Investigator (secondary) assessments., Part C only: Intracranial ORR by mRECIST v1.1 by Investigator assessment. Part C only: Intracranial ORR by RANO-BM by BICR and by Investigator assessment., PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC.

Interventions

DRUGVS-7375/GFH375

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed ORR by BICR per RECIST v1.1 (supported by DoR, as described below). Part C only: Intracranial ORR by mRECIST v1.1 by BICR., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, dose interruptions/reductions, and discontinuations.	—

Secondary

Measure	Time frame
All Parts: Confirmed ORR by Investigator-assessed DoR, BOR, DCR, PFS per RECIST v1.1, and OS. Unless otherwise specified, all response assessment‑based endpoints will be analyzed using BICR (primary) and Investigator (secondary) assessments., Part C only: Intracranial ORR by mRECIST v1.1 by Investigator assessment. Part C only: Intracranial ORR by RANO-BM by BICR and by Investigator assessment., PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 28, 2026