NCT03894540

Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours

A Phase I, Open Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumour Activity of IPN60090 as Single Agent and in Combination in Patients With Advanced Solid Tumours

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IPN60090	Oral capsules given daily
DRUG	pembrolizumab	An intravenous solution in single-use vial to be diluted for infusion.
DRUG	paclitaxel	An intravenous solution in single-use vial to be diluted for infusion.
DRUG	IPN60090 single administration	Oral capsules given once

Timeline

• Start date: 2019-03-22
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2019-03-28
• Last updated: 2022-09-13
• Results posted: 2021-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study