FRAME: A Phase I Trial of the Combination of VS-6063 (FAK Inhibitor) and RO5126766 (CH5126776) (a Dual RAF/MEK Inhibitor) in Patients With Advanced Solid Tumours

Trial ID # NCT03875820
Phase I
Drug Class Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/RAF-MEK
Drug Name VS-6766
Alternate Drug Names CKI27, RO5126766, Raf/MEK dual kinase inhibitor RO5126766, CH5126766
Drugs in Trial Defactinib, VS-6766
Eligible Participant

Recurrent low grade serous ovarian cancer

Patients Enrolled

25, median 4 prior therapies (1-9)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, PFS, evaluated per RECIST

Efficacy

RP2D [3.2 mg VS-6766 (2x/week)+200 mg defactinib (BID) q3/4 weeks]

ORR: 46% (n=24)
PFS: 23 months
11 KRAS MUT: ORR: 64%
9 KRAS WT: ORR: 44%

Conclusion

VS-6766 (CH5127677)+defactinib shows promising clinical activity in patients with low grade serous ovarian cancer including those who have been previously treated with a MEK inhibitor

Reference

Coma S et al. Synergistic antitumor efficacy of the dual RAF/MEK inhibitor VS-6766 with FAK inhibition for treatment of RAS-dependent solid tumor. Cancer Res (2021) Volume 81, Issue 13 Supplement, abstract 1425
https://cancerres.aacrjournals.org/content/81/13_Supplement/1425

Coma S et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2021/09/AACR-2021-VS-6766-Defactinib-poster.pdf

Banerjee S et al. Phase I study of the combination of the dual RAF/MEK inhibitor VS-6766 and the FAK inhibitor defactinib: Results of efficacy in low grade serous ovarian cancer. Annals of Oncology (2021) 32 (suppl_5): abstract 725MO
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/phase-i-study-of-the-combination-of-the-dual-raf-mek-inhibitor-vs-6766-and-the-fak-inhibitor-defactinib-results-of-efficacy-in-low-grade-serous-ov

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