NCT03009214

A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours

A Safety, Tolerability and Pharmacokinetic Dose Escalation and Expansion, Phase I/Ib Study of AMC303 as Monotherapy in Patients With Advanced or Metastatic, Malignant Solid Tumour of Epithelial Origin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: amcure GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be determined after completion of Part 1 considering safety and tolerability, also beyond the dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	AMC303	AMC303 is a CD44v6 inhibitor blocking receptor tyrosine kinase (RTK) pathways

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-07-28
• Completion: 2021-05-07
• First posted: 2017-01-04
• Last updated: 2021-05-10

Locations

7 sites across 2 countries: Belgium, Spain