NCT05234437

A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma

A Phase IIb, Multicentre, Open Label Study to Evaluate the Effectiveness, Safety and Tolerability of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: QBiotics Group Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma

Detailed description

Primary Objective 1. To evaluate the tumour responses of both injected and non injected tumours following treatment with intratumoural injections of tigilanol tiglate into one or more tumours (according to RECIST v1.1); and 2. To assess the tumour ablation rate following treatments with intratumoural injections of tigilanol tiglate. Secondary Objectives 1. To assess the tumour recurrence rate at injected tumour site(s); 2. To assess the safety and tolerability of intratumoural injections of tigilanol tiglate; 3. To assess the degree of wound healing at injection sites; and 4. To evaluate disease control by looking at Progression Free Survival (PFS) in melanoma participants receiving tigilanol tiglate injections over 36 months. Exploratory Objectives 1. To evaluate Overall Survival (OS) in melanoma participants receiving tigilanol tiglate injections over 36 months; 2. To assess the tumour microenvironment by looking at the degree of immune cell infiltration in non-injected tumours; and 3. To assess the Quality of Life (QoL) in melanoma participants receiving tigilanol tiglate injections.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	tigilanol tiglate	Single or multiple Intratumoural treatments of tigilanol tiglate up to a fixed dose level of 3.6mg/m2. Tigilanol tiglate is a novel, short-chain diterpene ester in early clinical development for local treatment of a wide range of solid tumours.

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2022-02-10
• Last updated: 2023-04-19

Locations

3 sites across 1 country: Australia