Pipeline

Robust Clinical Program: Avutometinib in Multiple Combinations Across
RAS/MAPK Pathway-Driven Tumors

Avutometinib

RAF/MEK Clamp

Avutometinib is a RAF/MEK Clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition.

Defactinib

Selective FAK Inhibitor

Defactinib is a best-in-class selective FAK inhibitor that has been studied as a monotherapy and in combination in patients with solid tumors.

Verastem-Sponsored TrialsInvestigator-Sponsored Trials
Indication Study Name Preclinical Phase 1 Phase 2 Phase 3

R/R LGSOC

Regimen: avutometinib + defactinib vs investigator's choice of treatments (ICT)

Study Name: RAMP 301

RAMP 301
Preclinical
Phase 1
Phase 2
Phase 3

R/R LGSOC

Regimen: avutometinib + defactinib

Study Name: IST-FRAME

IST-FRAME
Preclinical
Phase 1
Phase 2
Phase 3

R/R LGSOC1,2

Regimen: avutometinib +/- defactinib

Study Name: RAMP 201

RAMP 201
Preclinical
Phase 1
Phase 2
Phase 3

Gynecological Cancers (RAS Pathway-driven)3

Regimen: avutometinib + defactinib

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

Mesonephric

Regimen: avutometinib + defactinib

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

R/R NSCLC (BRAF mt)

Regimen: avutometinib + defactinib

Study Name: RAMP 202

RAMP 202
Preclinical
Phase 1
Phase 2
Phase 3

R/R NSCLC (KRAS G12C)

Regimen: avutometinib + sotorasib

Study Name: RAMP 203

RAMP 203
Preclinical
Phase 1
Phase 2
Phase 3

R/R NSCLC (KRAS G12C)

Regimen: avutometinib + adagrasib

Study Name: RAMP 204

RAMP 204
Preclinical
Phase 1
Phase 2
Phase 3

R/R NSCLC (KRAS mt)

Regimen: avutometinib + everolimus (mTORi)

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

Pancreatic Ductal Adenocarcinoma

Regimen: avutometinib + gemcitabine/nab-paclitaxel + defactinib

Study Name: RAMP 205

RAMP 205
Preclinical
Phase 1
Phase 2
Phase 3

R/R Colorectal Cancer

Regimen: avutometinib + cetuximab (EGFRi)

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

ER+ Breast Cancer

Regimen: avutometinib + abemaciclib + fulvestrant

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

BRAF V600E Melanoma3

Regimen: avutometinib + pembrolizumab

Study Name: IST

IST
Preclinical
Phase 1
Phase 2
Phase 3

GFH375/VS-7375

GFH375/VS-7375 is an orally bioavailable, potent and selective small molecule KRAS G12D (ON/OFF) inhibitor. Preclinical models demonstrate strong tumor regression as a single agent and support approaches in combination with Verastem Oncology’s RAF/MEK clamp avutometinib as well as other rational combinations across KRAS G12D-driven cancers.

Indication Study Name Preclinical Phase 1 Phase 2 Phase 3

KRAS G12D-mutant Solid Tumors

Regimen: KRAS G12D mutations

Preclinical
Phase 1
Phase 2
Phase 3

1FDA Breakthrough Therapy Designation
2Registration-directed trial
3Imminent initiation

These studies are investigating treatments or outcomes that have not received approval from a health authority. We are working diligently to demonstrate the safety and efficacy of these products, but there is no guarantee that the outcome of these studies will result in approval. We invite you to review our expanded access policy.

Investigator Sponsored Trials (IST)

We believe in the power of collaboration to help us push forward with new and promising cancer treatments. Our Verastem Oncology Investigator Sponsored Trial (IST) program strives to advance medical and scientific knowledge for our product candidates and disease states of interest. We welcome partnerships with researchers and sponsoring institutions that build on this mission.

 

Investigator Sponsored Trial Form

For additional details regarding our IST program or to submit a research request, please download, complete and submit the form below via email to verastem-IST@verastem.com.

 

Research Collaborations

Verastem Oncology also accepts proposals for preclinical research collaborations. For more information, please reach out to us at research@verastem.com.