Mobocertinib
EGFR/HER2 Inhibitor Non-Small Cell Lung Cancer with EGFR exon 20 insertion mutation
Overview1
Mobocertinib is an orally active epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) uniquely designed to optimize affinity and selectivity for EGFR Exon 20 insertions over wild type EGFR
MOA1,2
- Mobocertinib was uniquely designed as a potent inhibitor of EGFR and HER2 exon 20 insertions, with selectivity over wild type EGFR
- Mobocertinib binds to mutant EGFR and HER2 via irreversible covalent binding of EGFR-Cys797/HER2-Cys8052
Clinical Trials
Study Name
A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
CT.GOV ID
NCT04129502
Phase
Phase 3
Status
Recruiting
Study Name
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 in Non-Small Cell Lung Cancer
CT.GOV ID
NCT02716116
Phase
Phase 1/2
Status
Recruiting
Study Name
A Phase 1/2 Study of the Oral EGFR/HER2 Inhibitor TAK-788 in Japanese Non-Small Cell Lung Cancer Patients
CT.GOV ID
NCT03807778
Phase
Phase 1/2
Status
Recruiting
Study Name
A Phase 1 Pharmacokinetic Study of Oral Mobocertinib in Subjects With Severe Renal Impairment and Normal Renal Function
CT.GOV ID
NCT04056455
Phase
Phase 1
Status
Recruiting
Study Name
Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function
CT.GOV ID
NCT04056468
Phase
Phase 1
Status
Recruiting
References
1. Gonzalvez, et al. AACR 2016.
2. Chouitar J, et al. J Thorac Oncol. 2018:13:S811 [abstract P2.13-32].
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