NCT07644559

Brief 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 Pancreatic Cancer

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
30mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 26, 2026

Last Update Submit

June 8, 2026

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)G12D Mutated KRAS

Keywords

KRAS G12D mutationKRASPDACPancreatic Ductal AdenocarcinomaPancreatic CancerPancreatic NeoplasmsRAS

Outcome Measures

Primary Outcomes (2)

  • 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)

    6 months

  • 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.

    6 months

Secondary Outcomes (6)

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

    24 months

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

    20 weeks

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

    20 weeks

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

    Up to 2.5 years

  • To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30)

    24 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Imaging of tumor metabolism changes

    24 months

Study Arms (3)

VS-7375 Monotherapy

EXPERIMENTAL
Drug: VS-7375

VS-7375 + cetuximab 2L PDAC

EXPERIMENTAL
Drug: VS-7375Drug: cetuximab

VS-7375 + cetuximab 1L PDAC

EXPERIMENTAL
Drug: VS-7375Drug: cetuximab

Interventions

VS-7375DRUG

Taken by mouth

VS-7375 + cetuximab 1L PDACVS-7375 + cetuximab 2L PDACVS-7375 Monotherapy
cetuximabDRUG

Subcutaneous infusion

VS-7375 + cetuximab 1L PDACVS-7375 + cetuximab 2L PDAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathology 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
  • Adequate organ function
  • VS-7375 + cetuximab (2L PDAC) :
  • Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
  • VS-7375 + cetuximab (1L PDAC) :
  • Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease

You may not qualify if:

  • 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; RT to brain or lung within 2 weeks 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

START- Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Verastem Call Center

CONTACT

7812924204VS-7375-201TrialSupport@verastem.com

Luke Chung, MD

CONTACT

VS-7375-201Medical@verastem.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations

US(1)