NCT05669482: RAMP205

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

Active, enrolled Phase 1, PHASE2 Last updated 2 September 2025

What this trial tests

Phase 1, PHASE2 trial testing avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in KRAS Activating Mutation in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 March 2023

Primary endpoint
31 August 2026

31 August 2027

Quick facts

Lead sponsor	Verastem, Inc.
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	22 March 2023
Primary completion	31 August 2026
Estimated completion	31 August 2027
Sites	12 locations across United States

Drugs / interventions tested

• avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel — full drug profile →

Conditions studied

• KRAS Activating Mutation — all drugs for KRAS Activating Mutation →
• Metastatic Cancer — all drugs for Metastatic Cancer →
• Pancreas Cancer — all drugs for Pancreas Cancer →
• Neoplasms Pancreatic — all drugs for Neoplasms Pancreatic →

Sponsor

Verastem, Inc. — full company profile →

Who can join

18 and older, any sex, with KRAS Activating Mutation or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
   Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z
2. Targeting KRAS in cancer.
   Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0
3. Consensus, debate, and prospective on pancreatic cancer treatments.
   Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
4. Unraveling the Role of the Tumor Extracellular Matrix to Inform Nanoparticle Design for Nanomedicine.
   Cassani M, Fernandes S, Pagliari S, Cavalieri F, et al · · 2025 · cited 24× · PMID 39629891 · DOI 10.1002/advs.202409898
5. Stromal reprogramming overcomes resistance to RAS-MAPK inhibition to improve pancreas cancer responses to cytotoxic and immune therapy.
   Liu X, Baer JM, Stone ML, Knolhoff BL, et al · · 2024 · cited 22× · PMID 39441902 · DOI 10.1126/scitranslmed.ado2402
6. Targeting CRAF kinase in anti-cancer therapy: progress and opportunities.
   Wang P, Laster K, Jia X, Dong Z, et al · · 2023 · cited 22× · PMID 38111008 · DOI 10.1186/s12943-023-01903-x
7. Inhibition of the RAF/MEK/ERK Signaling Cascade in Pancreatic Cancer: Recent Advances and Future Perspectives.
   Adamopoulos C, Cave DD, Papavassiliou AG, Papavassiliou AG. · · 2024 · cited 19× · PMID 38338909 · DOI 10.3390/ijms25031631
8. Diffuse Gastric Cancer: A Comprehensive Review of Molecular Features and Emerging Therapeutics.
   Wu LW, Jang SJ, Shapiro C, Fazlollahi L, et al · · 2024 · cited 13× · PMID 39271577 · DOI 10.1007/s11523-024-01097-2