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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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