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

NCT05234437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-04-19

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • QBiotics Group Limited

    lead INDUSTRY

Principal Investigators

  • A/Prof. Robyn Saw, MBBS FRACS MS · Melanoma Institute Australia

  • Dr Megan Lyle, BMed FRACP · Cairns and Hinterland Hospital and Health Service

  • A/Professor Victoria Atkinson · Metro South Hospital and Health Service via Princess Alexandra Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2022-07-18
Completion
2022-07-18

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234437 on ClinicalTrials.gov