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Virus Therapy
Intratumoral IP-001 Injection for Solid Cancers (INJECTABL-1 Trial)
Phase 1 & 2
Recruiting
Led By Markus Jorger, MD
Research Sponsored by Immunophotonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
INJECTABL-1 Trial Summary
This trial will test a new drug to see if it's safe and effective to treat solid tumors after heat treatment.
Who is the study for?
This trial is for adults over 18 with Stage 3 or 4 colon cancer, non-small cell lung cancer, or soft tissue sarcoma who've tried up to four treatments without success. They need good blood, liver and kidney function, a life expectancy over six months, and tumors accessible for ablation no larger than 5 cm. Participants must not be pregnant and agree to use contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of IP-001 injected directly into tumors after heating them (thermal ablation). It aims to see if this treatment can help patients whose cancers haven't responded well to other therapies.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical reactions related to intratumoral injections such as pain at injection site, inflammation around the tumor area, possible allergic reactions or systemic effects depending on how IP-001 works within the body.
INJECTABL-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys work well, with a creatinine clearance rate of 50 mL/min or more.
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I am using effective birth control and, if female, have a negative pregnancy test.
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My blood counts meet the required levels for treatment.
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My doctor expects me to live more than 6 months and my largest cancer lesion is 5 cm or smaller.
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My cancer is advanced and I've tried up to 4 treatments without success.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have a tumor larger than 1 cm that can be treated without surgery.
INJECTABL-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC)
Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC)
Efficacy: Disease-free survival (DFS)
+13 moreINJECTABL-1 Trial Design
3Treatment groups
Experimental Treatment
Group I: Soft Tissue Sarcoma (STS)Experimental Treatment1 Intervention
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
Group II: Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
Group III: Colorectal Cancer (CRC)Experimental Treatment1 Intervention
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
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Who is running the clinical trial?
Immunophotonics, Inc.Lead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
Markus Jorger, MDPrincipal InvestigatorCantonal Hospital of St. Gallen
Diane Beatty, PhDStudy DirectorImmunophotonics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using effective birth control and, if female, have a negative pregnancy test.My blood counts meet the required levels for treatment.My liver tests are within the required range.My doctor expects me to live more than 6 months and my largest cancer lesion is 5 cm or smaller.My kidneys work well, with a creatinine clearance rate of 50 mL/min or more.I am currently taking steroids or other drugs that affect my immune system.I have mostly recovered from side effects of my previous treatments.I haven't had chemotherapy, radiotherapy, immunotherapy, or experimental drugs in the last 21 days.Your bone marrow is working properly and you have enough white blood cells, platelets, and red blood cells.You have a documented diagnosis of HIV.I have a brain tumor or cancer that has spread to my brain.I have had cancer before, but it was not melanoma or a cancer that was only on the surface.My cancer is advanced and I've tried up to 4 treatments without success.I am 18 years old or older.I am fully active or can carry out light work.I do not have an active Hepatitis B or C infection.I cannot stop my blood thinner medication for 24 hours before the trial treatment.I have a tumor larger than 1 cm that can be treated without surgery.You have a disease that can be measured using a specific set of guidelines.I do not have severe heart problems.
Research Study Groups:
This trial has the following groups:- Group 1: Soft Tissue Sarcoma (STS)
- Group 2: Non-Small Cell Lung Cancer (NSCLC)
- Group 3: Colorectal Cancer (CRC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the extent of implementation for this trial across healthcare establishments?
"Participants for this trial can be recruited from Stephenson Cancer Center in Oklahoma City, Johann Wolfgang Goethe-Univresitat Frankfurt/Main in Frankfurt, SLK-Kliniken Heilbronn GmbH in Heilbronn and a further 13 sites."
Answered by AI
Are there any openings remaining for participants in this research endeavor?
"Indeed, current information from clinicaltrials.gov verifies that this medical trial is actively seeking participants. The study was originally posted on November 29th 2022 and the most recent update was 8/8/2023. A total of 44 patients must be enrolled across 16 sites."
Answered by AI
How many individuals have participated in this experiment thus far?
"Yes, the online registry clinicaltrials.gov reveals that this medical study is actively recruiting and was initially posted on November 29th 2022. The trial has recently been modified as of August 8th 2023, with 44 participants being sought from 16 sites."
Answered by AI
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