A Phase 1/2 interventional study of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in KRAS Activating Mutation, Metastatic Cancer and Pancreas Cancer, sponsored by Verastem, Inc.. Active, not recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Verastem, Inc. · Phase 1/2, Interventional, and Treatment
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.
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).
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 40 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Verastem, Inc. is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
Drug: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients
Drug: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
The RP2D of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel determined in Part A will be used in Part B dose expansion.
Also known as: Gemzar, Abraxane
Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel
Assessment of Dose-limiting toxicities (DLTs)
Time frame: 28 days
To determine the efficacy of the RP2D identified in Part A
Confirmed overall response rate (ORR) (partial response \[PR\] + complete response \[CR\] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\])
Time frame: 6 months
Duration of Response (DOR)
Time of first response to PD as assessed per RECIST 1.1
Time frame: 24 months
Disease Control Rate (DCR)
CR + PR + SD as assessed per RECIST 1.1
Time frame: 24 months
Progression Free Survival (PFS)
From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause
Time frame: 24 months
Overall Survival (OS)
From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause
Time frame: Up to 5 years
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Tmax
Time to Maximum concentration (Tmax)
Time frame: 10 weeks
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, AUC
Area under plasma Concentration (AUC) 0 to t
Time frame: 10 Weeks
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Half-life
concentration Half-life (T1/2)
Time frame: 10 weeks
Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
Time frame: 24 months
Number of abnormal laboratory values
Count of abnormal laboratory values by grade
Time frame: 24 months
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Verastem, Inc.