Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS

NCT05688280 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IP-IIO-622
• Study Type: interventional
• Target: 42
• Locations: 5 countries
• Sites: 16

Brief Summary

The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.

Conditions

Metastatic Solid Tumor; Colon Cancer; Nonsmall Cell Lung Cancer; Soft Tissue Sarcoma

Keywords

Cancer; Anti-cancer drug or therapy; Advanced solid tumors; Intratumoral injection; IP-001; Thermal ablation; Phase lb/lla; Melanoma; Soft tissue sarcoma; Tumor ablation; Systemic immune response; Interventional immuno-oncology; Interventional oncology; Abscopal effect; T-cell stimulation

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  The assessment of safety will be based on incidence of adverse events.

  Up to 12 weeks

Secondary Outcomes (16)

• Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC)

  Up to 12 weeks

• Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC)

  Up to 12 weeks

• Efficacy: Objective response according to iRECIST (iOR)

  Up to 12 weeks

• Efficacy: Duration of response according to iRECIST (iDOR)

  Up to 12 weeks

• Efficacy: Progression-free survival according to iRECIST (iPFS)

  Up to 12 weeks

Study Arms (3)

Colorectal Cancer (CRC)

EXPERIMENTAL

Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.

Drug: 1.0% IP-001 for Injection

Non-Small Cell Lung Cancer (NSCLC)

EXPERIMENTAL

Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.

Drug: 1.0% IP-001 for Injection

Soft Tissue Sarcoma (STS)

EXPERIMENTAL

Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.

Drug: 1.0% IP-001 for Injection

Interventions

1.0% IP-001 for Injection DRUG

4 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments.

Also known as: IP-001

Colorectal Cancer (CRC); Non-Small Cell Lung Cancer (NSCLC); Soft Tissue Sarcoma (STS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 3 or Stage 4 CRC, NSCLC, or STS who have failed, are ineligible, refused, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy
• Life expectancy of \> 6 months. Only have lesions with the longest diameter of ≤ 5 cm.
• Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm.
• Measurable disease according to RECIST 1.1.
• Age ≥ 18 years.
• ECOG performance status 0-1.
• Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
• Adequate hematological function defined by white blood cell count ≥ 2.5 × 109/L with absolute neutrophil count ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (transfusions allowed on study).
• Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all patients, or for patients with documented metastatic disease to the liver and AST and ALT levels ≤ 5 × ULN. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN.
• Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).

You may not qualify if:

• Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.
• Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease.
• Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment.
• Patients who have not recovered to common terminology criteria for adverse events (CTCAE) Grade ≤ 1 from all side effects of prior therapies except for residual toxicities.
• Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.
• Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy.
• Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment.
• Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).
• Documented HIV positive.
• Active Hepatitis C or Hepatitis B Viral infection.

Sponsors & Collaborators

• Immunophotonics, Inc.: lead

Study Sites (16)

Miami Cardiac & Vascular Institute

Coral Gables, Florida, 33146, United States

Location

University of Louisville Physicians, PSC

Louisville, Kentucky, 40202, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Johann Wolfgang Goethe-Univresitat Frankfurt/Main

Frankfurt, 60590, Germany

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078, Germany

Location

Munchen Klinik Bogenhausen

Munich, 81925, Germany

Location

IOSI Ospedale San Giovanni Bellinzona

Bellinzona, 6500, Switzerland

Location

Inselspital Universitatsspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Graubunden

Chur, 7000, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

University College London Hospitals

London, W1T 7HA, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung; Sarcoma; Neoplasms; Melanoma

Interventions

N-dihydrogalactochitosan; Injections

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Markus Jorger, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

• Diane Beatty, PhD

  Immunophotonics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label study with 3 Cohorts * Cohort 1: 18 patients with Stage 3 or Stage 4 Colorectal Cancer (CRC) * Cohort 2: 17 patients with Stage 3 or Stage 4 Non-Small Cell Lung Cancer (NSCLC) * Cohort 3: 3 patients with Stage 3 or Stage 4 Soft Tissue Sarcoma (STS) There will be 3 study periods: a Pretreatment Period, a Treatment Period, and a Follow-up Period.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 18, 2023
• Study Start: November 29, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); DE (3); CH (4); US (3); FR (4)