Health Trials

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVerastem, Inc.

About this trial

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathology confirmed metastatic CRC

Measurable disease per RECIST 1.1

Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

ECOG PS=0 or 1

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • VS-7375

    Drug

    Taken by mouth

  • cetuximab

    Drug

    Intravenous infusion

  • panitumumab

    Drug

    Intravenous infusion

  • Cetuximab + mFOLFOX6

    Drug

    Intravenous infusion

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: VS-7375 Monotherapy or Preferred Combination in 2L+ CRCExperimental treatment 3 interventions
Group B: VS-7375 with chosen regimen in 2L+ CRCExperimental treatment 3 interventions
Group C: VS-7375 + cetuximab and mFOLFOX in 1L CRCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only

Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)

Time frame
6 months
2

To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab or panitumumab, administered on a daily oral schedule in participants with KRAS G12D-mutated 2L+ CRC

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

Time frame
6 months
3

To characterize the safety and tolerability of VS-7375 in combination with cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated 1L CRC

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

Time frame
6 months

Secondary outcomes

1

Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments

To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab or panitumumab or cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated CRC

Time frame
24 months
2

Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax

Maximum concentration (Cmax)

Time frame
20 weeks
3

Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC

Area under plasma Concentration (AUC) 0 to t

Time frame
20 weeks
4

To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type

CA19-9, CEA, CA-125

Time frame
Up to 2.5 years

Other outcomes

1

Imaging of tumor metabolism changes in 2L monotherapy patients

To assess tumor metabolism dynamics on FDG-PET/CT

Time frame
24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Verastem, Inc.

Lead sponsor

Source ClinicalTrials.gov
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