NCT04036682

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

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Cullinan Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.

Detailed description

This is a Phase 1/2, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and 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 multiple parts: Phase 1 Dose Escalation, Phase 2a Dose Expansion, Module A, Module B, and Module C. The objectives of the dose escalation and dose expansion parts are to determine the safety, tolerability, recommended Phase 2 dose (RP2D), and preliminary anti-tumor activity of orally administered CLN-081 monotherapy. The objective of Module A is to preliminarily assess the effect of food on the PK profile of CLN-081. The objective of Module B is to further characterize the safety and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior systemic anti-cancer treatment for locally advanced or metastatic disease. The objective of Module C is to explore the safety, tolerability, and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior treatment with an agent approved for EGFR exon 20 insertion mutant NSCLC CLN-081 will be dosed twice daily (BID).

Conditions

• Non Small Cell Lung Cancer
• EGFR Exon 20 Mutation

Interventions

Type	Name	Description
DRUG	CLN-081	CLN-081 tablets

Timeline

• Start date: 2019-10-31
• Primary completion: 2026-01-31
• Completion: 2026-03-31
• First posted: 2019-07-30
• Last updated: 2025-03-13

Locations

64 sites across 9 countries: United States, Hong Kong, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study