Last updated on May 2020

A Phase 1/2a Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

Brief description of study

CLN-081-101 is a Phase 1/2a, open label, multi-center study of CLN-081 in patients with NSCLC (non small cell lung cancer) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Detailed Study Description

This is a Phase 1/2a, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This trial is divided into three parts: Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion.

The objectives of the dose escalation part are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), and to evaluate the anti-tumor activity of orally administered CLN-081 monotherapy. Additional objectives are to determine the pharmacokinetic (PK) profile of CLN-081 and CLN-081's activity in patients with known central nervous system (CNS) disease.

CLN-081 will be dosed once daily (QD) and twice daily (BID).

Clinical Study Identifier: NCT04036682

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