NX-019 / Nalo Therap - LARVOL DELTA

A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer (clinicaltrials.gov) - P1 | N=258 | Active, not recruiting | Sponsor: Nalo Therapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2027 ➔ Dec 2025 | Trial primary completion date: Feb 2027 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • EGFR

A Study of NX-019 in Patients With Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer (clinicaltrials.gov) - P1 | N=258 | Recruiting | Sponsor: Nalo Therapeutics Inc. | N=178 ➔ 258

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • EGFR

A first-in-human, open-label, dose escalation and expansion study of orally administered NX-019 in patients with advanced EGFR mutant cancer. (ASCO 2023) - P1 | "Part 2 will enroll patients in 5 cohorts (n = 10 or 29 each), including patients with NSCLC who have (1) new or progressing CNS metastases including leptomeningeal disease after treatment with osimertinib, (2) active CNS disease and ex20ins mutations, (3) ex20ins mutations without CNS disease and (4) other rare mutations, based on a Simon 2-stage design. The study is planned for approximately 35 centers in North America and Asia-Pacific region. Clinical trial information: NCT05514496."

Clinical • Metastases • P1 data • CNS Disorders • CNS Tumor • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • RET

NX-019 shows potency and selectivity in preclinical models of EGFR-mutant tumors (Bioworld) - "Researchers from Nalo Therapeutics Inc. presented the discovery and preclinical evaluation of a novel orally bioavailable and brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, NX-019, being developed as a potential therapeutic agent to treat EGFR-mutant solid tumors."

Preclinical • Oncology • Solid Tumor

NX-019, a brain penetrant, mutation selective EGFR inhibitor with broad mutant EGFR activity (ESMO Asia 2022) - "CNS exposure studies in multiple preclinical species shows a Kp,uu of approximately 1 indicating excellent CNS exposure. Conclusions Based on the preclinical profile of broad potency and mutant selectivity for EGFR mutations with excellent CNS exposure, NX-019 is entering a Phase I dose escalation and dose expansion trial in mutant EGFR selected patients."

Dermatology • Oncology

A Study of NX-019 in Patients With Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer (clinicaltrials.gov) - P1 | N=178 | Recruiting | Sponsor: Nalo Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study of NX-019 in Patients With Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer (clinicaltrials.gov) - P1 | N=178 | Not yet recruiting | Sponsor: Nalo Therapeutics Inc.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR