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

NCT03993678 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-30

No results posted yet for this study

Summary

The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.

Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as, long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).

This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2).

The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to 6 scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device, and IP-001 will be administered in different dose levels according to the trial design. All patients will be followed until progression of disease or until the start of a subsequent treatment.

Conditions

Interventions

DRUG

IP-001

Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level.

DEVICE

Thermal Ablation

The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments. Treatment time: 30 min

Sponsors & Collaborators

  • Immunophotonics, Inc.

    collaborator INDUSTRY

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Markus Joerger, MD PhD · Cantonal Hospital of St. Gallen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2025-07-15
Completion
2025-07-19

Countries

  • Switzerland

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 NCT03993678 on ClinicalTrials.gov