Trial intelligence / Profile preview

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors

NCT03993678Phase 2

Key facts

Status: Completed
Start: Oct 2020
Primary completion: Jul 2025
Countries: 1
Sponsor: Swiss Group for Clinical Cancer Research
Modality: Injectable Hydrogels, Implantable Hydrogels, Vaccines & Immunotherapeutics

Drugs: IP-001
Conditions: solid tumor (advanced stage)soft tissue sarcoma (STS)melanoma

Overview

Phase 2, open-label, single-arm trial of IP-001 in solid tumor (advanced stage), soft tissue sarcoma (STS) and melanoma, sponsored by Swiss Group for Clinical Cancer Research. Primary endpoints: Dose-limiting toxicity at 28 days and Disease control according to RECIST 1.1 at 12 weeks. Started Oct 2020; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Ablation + IP-001
Thermal ablation followed immediately by intratumoral injection of IP-001.

Who it enrols

Adult patients with advanced or recurrent solid tumors (including soft tissue sarcoma and melanoma) who have failed standard therapy, with at least one laser ablation-accessible lesion, adequate organ function, and no active autoimmune disease or severe cardiovascular disease.

Endpoints

Primary

Dose-limiting toxicity28 days
Disease control according to RECIST 1.112 weeks

Secondary

Objective response according to iRECIST12 weeks
Disease control according to iRECIST12 weeks
Duration of response according to iRECIST4 years
Progression-free survival according to iRECIST4 years
Objective response according to RECIST 1.124 weeks
Disease control according to RECIST 1.124 weeks
Duration of response according to RECIST 1.14 years
Progression-free survival according to RECIST 1.14 years

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