How many clinical trials are studying Avutometinib?

4 recruiting trials in our tracked data involve Avutometinib.

What conditions is Avutometinib being studied for?

In our tracked recruiting trials, Avutometinib is being studied in trials for Advanced Colorectal Cancer, Advanced Lung Adenocarcinoma, Brain Metastases.

Avutometinib: clinical trials recruiting now

Q: Is Avutometinib FDA-approved?

Yes. According to the FDA drug label available through openFDA, Avutometinib is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Avutometinib appears in the FDA drug-label database. Marketed as AVMAPKI FAKZYNJA CO-PACK.

FDA-approved use

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 , 14 )

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 4

Conditions being studied

Condition	Trials
Advanced Colorectal Cancer	1
Advanced Lung Adenocarcinoma	1
Brain Metastases	1
Cancer of the Pancreas	1
Colorectal cancer	1
Cutaneous Melanoma	1
Lung cancer	1
Melanoma	1
Pancreas Cancer	1
Pancreatic Adenocarcinoma	1
Pancreatic Cancer	1
Refractory Lung Adenocarcinoma	1
Stage III Lung Cancer AJCC v8	1
Stage IV Lung Cancer AJCC v8	1

Recruiting trials involving Avutometinib

Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma
NCT06194929 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 2 locations
Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
NCT06495125 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 3 locations
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
NCT06369259 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma
NCT07126158 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Avutometinib FDA-approved?

Yes, marketed as AVMAPKI FAKZYNJA CO-PACK.

How many recruiting trials involve Avutometinib?

4 recruiting trials across 14 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.