Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer (RAMP205)

V

Verastem

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Metastatic Cancer
KRAS Activating Mutation
Neoplasms Pancreatic
Pancreas Cancer
Malignant Neoplasm of Pancreas

Treatments

Drug: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05669482
VS-6766-205

Details and patient eligibility

About

This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.

Full description

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients previously untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Male or female subjects ≥ 18 years of age * Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma. * An Eastern Cooperative Group (ECOG) performance status ≤ 1 * Measurable disease according to RECIST 1.1 * Adequate organ function * Adequate cardiac function * Agreement to use highly effective method of contraceptive

Exclusion criteria

* Patients with pancreatic neuroendocrine tumors * Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma * Prior treatment with inhibitors of the RAS /MAPK pathway \[e.g. MEK inhibitors\] or inhibitors of FAK * History of prior malignancy, with the exception of curatively treated malignancies * Major surgery within 4 weeks (excluding placement of vascular access) * Concurrent heart disease or severe obstructive pulmonary disease * Concurrent ocular disorders * Active skin disorder that has required systemic therapy within the past 1 year * Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome * Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
Experimental group
Description:
To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
Treatment:
Drug: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
Experimental group
Description:
To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients
Treatment:
Drug: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel

Trial contacts and locations

11

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Central trial contact

Verastem Call Center

Data sourced from clinicaltrials.gov

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