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DRUG CLASS:

cRAF inhibitor

4d
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma (clinicaltrials.gov)
P1, N=50, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2026 --> Jul 2027
Trial completion date
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BRAF V600
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Opdivo (nivolumab) • Mektovi (binimetinib) • Braftovi (encorafenib)
4d
Trial completion date
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600 • BRAF V600K
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Keytruda (pembrolizumab) • Mektovi (binimetinib) • Braftovi (encorafenib)
7d
SEACRAFT-1: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations (clinicaltrials.gov)
P1, N=86, Active, not recruiting, Erasca, Inc. | Trial completion date: Nov 2025 --> Dec 2026
Trial completion date
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RAS mutation
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Mekinist (trametinib) • naporafenib (ERAS-254)
7d
Real-world outcomes of encorafenib, cetuximab ± binimetinib for BRAF‑mutated metastatic colorectal cancer: The BEETS (JACCRO CC‑18) study. (PubMed, Oncologist)
In real-world clinical practice, triplet and doublet therapies showed comparable survival outcomes, consistent with the BEACON trial. Triplet therapy may provide potential clinical benefit in patients with poor PFs.
Journal • Real-world evidence
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BRAF (B-raf proto-oncogene) • CRP (C-reactive protein)
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BRAF V600E • BRAF mutation • BRAF V600
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Erbitux (cetuximab) • Mektovi (binimetinib) • Braftovi (encorafenib)
7d
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) (clinicaltrials.gov)
P3, N=78, Active, not recruiting, Erasca, Inc. | Recruiting --> Active, not recruiting | N=470 --> 78
Enrollment closed • Enrollment change
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NRAS (Neuroblastoma RAS viral oncogene homolog)
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NRAS mutation
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Mekinist (trametinib) • temozolomide • dacarbazine • naporafenib (ERAS-254)
17d
PATH: Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients (clinicaltrials.gov)
P1, N=30, Completed, Zhejiang University | Recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2025 | Trial primary completion date: Dec 2023 --> Nov 2025
Trial completion • Trial completion date • Trial primary completion date
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Zepsun (donafenib)
19d
Synergistic antitumor effect of oroxylin A and donafenib in hepatocellular carcinoma through tumor protein p53 signaling pathway activation. (PubMed, World J Gastroenterol)
Oroxylin A and donafenib exert a synergistic anti-tumor effect in HCC by co-activating the TP53 signaling pathway through distinct but complementary molecular axes. This combination strategy presents a promising and viable therapeutic approach to overcome the limitations of donafenib monotherapy in the treatment of HCC.
Journal
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MDM4 (The mouse double minute 4) • CDK9 (Cyclin Dependent Kinase 9)
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Zepsun (donafenib)
21d
Effects of Cytochrome P450 enzymes and drug-drug interaction on donafenib metabolism: in vivo, in vitro and in silico. (PubMed, Bioorg Chem)
This study systematically elucidated the metabolic characteristics of the hepatocellular carcinoma (HCC) therapeutic drug donafenib and its drug-drug interaction (DDI) with the antiviral agent arbidol. Moreover, Tmax was prolonged by 68.42%, while CLz/F was decreased by 53.85%. These results provided critical references for clinical dosage adjustment, facilitating personalized treatment and reducing the risk of adverse reactions.
Preclinical • Journal
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CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
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Zepsun (donafenib)
23d
Safety and Efficacy of Triple Therapy Containing Encorafenib, Cetuximab, and Binimetinib for BRAF V600E-Mutated Colorectal Cancer: a Systematic Review and Meta-Analysis. (PubMed, J Gastrointest Cancer)
Triple therapy with encorafenib, cetuximab, and binimetinib offers meaningful improvements in survival and tumor response in BRAF V600E-mutated CRC, although the toxicity remains substantial. Optimizing patient selection and managing adverse events are critical for broader clinical use.
Clinical • Retrospective data • Review • Journal
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600
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Erbitux (cetuximab) • Mektovi (binimetinib) • Braftovi (encorafenib)
24d
Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer (clinicaltrials.gov)
P2, N=33, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Feb 2026 --> Feb 2029
Trial completion date • Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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BRAF V600E • BRAF V600 • BRAF wild-type
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Erbitux (cetuximab) • Avmapki (avutometinib) • Fakzynja (defactinib)