A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526473-42-00

Enrollment

Registered

2026-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-21

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

Conditions

Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma

Brief summary

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

Detailed description

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. Confirmed ORR by Investigator-assessed DoR, BOR, DCR, PFS per RECIST v1.1, and OS. PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC.

Interventions

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

DRUGFolinsäure PhaRes 10 mg/ml Injektionslösung

DRUGOxaliplatin AqVida 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGErbitux 5 mg/mL solution for infusion

DRUGFluorouracil PhaRes 50 mg/ml Injektionslösung

DRUGVS-7375/GFH375

DRUGOxaliplatin Hikma 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGVectibix 20 mg/ml concentrate for solution for infusion

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). Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, dose interruptions/reductions, and discontinuations. Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, DLTs, dose interruptions/reductions, and discontinuations.	—

Secondary

Measure	Time frame
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. Confirmed ORR by Investigator-assessed DoR, BOR, DCR, PFS per RECIST v1.1, and OS. PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 22, 2026