NCT03037385

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 590 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

Detailed description

The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the participants must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.

Conditions

• RET-altered Non Small Cell Lung Cancer
• Medullary Thyroid Cancer
• RET-altered Papillary Thyroid Cancer
• RET-altered Colon Cancer
• RET-altered Solid Tumors
• Lung Neoplasm
• Carcinoma, Non-Small-Cell Lung
• Thyroid Diseases
• Thyroid Neoplasm
• Thyroid Cancer, Papillary
• Carcinoma, Neuroendocrine
• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Disease
• Carcinoma, Bronchogenic
• Bronchial Neoplasms
• Endocrine System Diseases
• Endocrine Gland Neoplasm
• Head and Neck Neoplasms
• Adenocarcinoma, Papillary
• Adenocarcinoma
• Carcinoma
• Neoplasms, Glandular and Epithelial
• Neoplasms by Histologic Type
• Neuroendocrine Tumors
• Neuroectodermal Tumors
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Nerve Tissue
• Colonic Neoplasms
• Colorectal Neoplasms
• Intestinal Neoplasms
• Gastrointestinal Neoplasms
• Digestive System Neoplasm
• Digestive System Disease
• Gastrointestinal Disease
• Colonic Diseases
• Intestinal Disease

Interventions

Type	Name	Description
DRUG	pralsetinib (BLU-667)	pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants

Timeline

• Start date: 2017-03-17
• Primary completion: 2024-03-21
• Completion: 2024-03-21
• First posted: 2017-01-31
• Last updated: 2025-05-31
• Results posted: 2025-05-31

Locations

71 sites across 13 countries: United States, Belgium, China, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study