Active Not RecruitingPhase 1 / Phase 2NCT05688280
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied1.0% IP-001 for Injection

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 8, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?Immunophotonics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Immunophotonics, Inc.
Interventions being studied
Drug: 1.0% IP-001 for Injection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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 2. Life expectancy of \> 6 months. Only have lesions with the longest diameter of ≤ 5 cm. 3. Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm. 4. Measurable disease according to RECIST 1.1. 5. Age ≥ 18 years. 6. ECOG performance status 0-1. 7. Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L. 8. 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). 9. 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. 10. Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). 11. Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion.

Reasons someone may not be able to joinExclusion criteria

1. Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment. 2. Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease. 3. Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment. 4. 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. 5. Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers. 6. Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy. 7. Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment. 8. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV). 9. Documented HIV positive. 10. Active Hepatitis C or Hepatitis B Viral infection.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Miami Cardiac & Vascular InstituteCoral Gables, Florida
  • University of Louisville Physicians, PSCLouisville, Kentucky
  • Stephenson Cancer CenterOklahoma City, Oklahoma
  • Institut BergonieBordeaux
  • Hospitalier Pitie-SalpetriereParis
  • Hôpital FochSuresnes
  • Institut Gustave RoussyVillejuif
  • Johann Wolfgang Goethe-Univresitat Frankfurt/MainFrankfurt
  • SLK-Kliniken Heilbronn GmbHHeilbronn
  • Munchen Klinik BogenhausenMunich
  • IOSI Ospedale San Giovanni BellinzonaBellinzona
  • Inselspital Universitatsspital, BernBern

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 8, 2025. Always confirm current availability with the study team.

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