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

ConditionsPancreatic Ductal Adenocarcinoma (PDAC)G12D Mutated KRAS
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 in patients with metastatic KRAS G12D - mutated Pancreatic Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic or cytologic 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

Disqualifiers

Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VS-7375

    Drug

    Taken by mouth

  • cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)

    Drug

    Subcutaneous infusion

Treatment groups

185 Participants
are divided into 3 treatment groups
Group A: VS-7375 MonotherapyExperimental treatment 1 intervention
Group B: VS-7375 + cetuximab 2L PDACExperimental treatment 2 interventions
Group C: VS-7375 + cetuximab 1L PDACExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1

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, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.

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, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.

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

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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