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Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor

NCT04416516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-10

No results posted yet for this study

Summary

The primary objectives are to:

1. Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s;
2. Evaluate the efficacy of intralesional ASN-002 in target tumours when administered in combination with oral vismodegib in patients with BCCs.

The secondary objective is to:

1\) Evaluate the efficacy of intralesional ASN-002 in non-target tumours when administered in combination with oral vismodegib in patients with BCCs.

The exploratory objective is to:

1\) Evaluate immunological biomarkers during the course of treatment.

Conditions

Interventions

BIOLOGICAL

ASN-002

ASN-002 has been designed for clinical applications, especially for intratumoral administration in the treatment of various cancers. This rAd vector delivers the gene of interest, in the case of ASN-002 the human IFNγ gene, into target cells. The rAd vector in ASN-002 is replication deficient and although it infects cells, it is not able to replicate in the tumor or in normal human cells. The infected cells are able to transcribe and translate the IFNγ DNA leading to a sustained local concentration of IFNγ in the tumor mass that is designed to avoid high levels of systemic IFNγ that may be lead to unacceptable toxicity.

Sponsors & Collaborators

  • Ascend Biopharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Clement Leong, Ph.D · Ascend Biopharmaceuticals Ltd

  • Gregory Siller · Central Brisbane Dermatology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2024-02-14
Completion
2024-02-14

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 NCT04416516 on ClinicalTrials.gov