NCT05752552

Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours

A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET Kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: DeuterOncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative. The dose escalation is completed, Part 2 of the study is ongoing.

Detailed description

In Part 1, a Simon Design 3 accelerated titration design will be followed. One patient will be enrolled per cohort, until grade 2 toxicity is observed. Three sequential patients per cohort will be enrolled thereafter, with a minimum of 1 week between first dose administration in the first patient and the subsequent ones, in those latter cohorts. In part 2, up to 30 evaluable patients with locally advanced, unresectable or metastatic non-small-cell cancer (NSCLC), no longer eligible for approved, available standard therapies and having tumour harbouring MET exon14 skipping mutation from an assessment not older than 3 months, will received DO-2 at the selected dose.

Conditions

• Adult Solid Tumor
• Advanced Solid Tumor
• Refractory Tumor
• Non-small Cell Lung Cancer
• Non-small Cell Carcinoma
• Lung Cancer
• Hereditary Renal Papillary Cancer

Interventions

Type	Name	Description
DRUG	DO-2	Deuterated MET kinase inhibitor

Timeline

• Start date: 2022-12-20
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2023-03-02
• Last updated: 2026-04-03

Locations

13 sites across 3 countries: Belgium, France, Netherlands