~13 spots leftby Apr 2026

Intratumoral IP-001 Injection for Solid Cancers

(INJECTABL-1 Trial)

Recruiting in Palo Alto (17 mi)
+16 other locations
MJ
Overseen byMarkus Jorger, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Immunophotonics, Inc.
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic corticosteroids, other immunosuppressive therapy, or anti-coagulation therapies that can't be stopped 24 hours before treatment. Also, you must not have received chemotherapy, radiotherapy, immunotherapy, or other investigational agents within 21 days prior to treatment.

What data supports the idea that Intratumoral IP-001 Injection for Solid Cancers is an effective treatment?

The available research shows that Intratumoral IP-001 Injection can effectively stimulate the body's immune response against cancer. By injecting the treatment directly into the tumor, it helps activate the immune system locally, which can then lead to a broader, long-lasting response throughout the body. This method reduces the risk of severe side effects compared to treatments given through the bloodstream. Studies have shown that this approach can be more effective and safer, especially when combined with other cancer treatments. For example, it has been successful in treating melanoma, a type of skin cancer, and is being tested for other cancers as well.12345

What safety data exists for Intratumoral IP-001 Injection for Solid Cancers?

The provided research does not directly mention IP-001 or its safety data. However, it discusses the safety of intratumoral chemotherapy and immunotherapy approaches, which are relevant to IP-001. Intratumoral delivery of chemotherapy, such as mitoxantrone-loaded albumin microspheres, has shown reduced systemic toxicity in a murine breast cancer model. Additionally, intratumoral immunotherapy is highlighted for minimizing off-target toxicities compared to systemic delivery. These findings suggest that intratumoral approaches, like IP-001, may offer safety advantages by reducing systemic side effects.56789

Is the treatment IP-001 a promising treatment for solid cancers?

Yes, IP-001 is promising because it can be injected directly into tumors, which helps to boost the body's immune response against cancer while reducing side effects. This approach allows for high concentrations of the treatment in the tumor, making it more effective and safer than traditional methods.12356

Research Team

DB

Diane Beatty, PhD

Principal Investigator

Immunophotonics, Inc.

MJ

Markus Jorger, MD

Principal Investigator

Cantonal Hospital of St. Gallen

Eligibility Criteria

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.

Inclusion 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.
See 8 more

Exclusion Criteria

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.
See 7 more

Treatment Details

Interventions

  • IP-001 (Virus Therapy)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Miami Cardiac & Vascular InstituteCoral Gables, FL
Stephenson Cancer CenterOklahoma City, OK
University of Louisville Physicians, PSCLouisville, KY
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Who Is Running the Clinical Trial?

Immunophotonics, Inc.

Lead Sponsor

Trials
3
Patients Recruited
210+

Findings from Research

The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy.Brito-Orama, S., Sheth, RA.[2023]
Intratumoral immunotherapy: using the tumor as the remedy.Marabelle, A., Tselikas, L., de Baere, T., et al.[2021]
Intratumoural immunotherapies in oncology.Xu, W., Atkinson, VG., Menzies, AM.[2020]
Direct intratumoral injection of immunotherapeutic agents can lead to local immune activation while reducing systemic toxicity, making it a safer alternative to intravenous administration.
Intratumoral delivery has shown improved efficacy and the potential for abscopal effects, especially when combined with immune checkpoint inhibitors, highlighting its promise in cancer treatment.
Delivery routes matter: Safety and efficacy of intratumoral immunotherapy.De Lombaerde, E., De Wever, O., De Geest, BG.[2021]
Intratumoral Immunotherapy for Early-stage Solid Tumors.Hong, WX., Haebe, S., Lee, AS., et al.[2021]
Efficacy of mitoxantrone-loaded albumin microspheres for intratumoral chemotherapy of breast cancer.Almond, BA., Hadba, AR., Freeman, ST., et al.[2019]
Phase II study of cisplatin with irinotecan as induction chemotherapy followed by chemoradiotherapy for unresectable stage III non-small cell lung cancer.Chang, H., Kim, SH., Cho, BC., et al.[2018]
The study involved 60 patients with advanced ovarian cancer receiving a regimen of intravenous docetaxel and intraperitoneal cisplatin and paclitaxel, showing a tolerability profile with manageable toxicities, primarily neutropenia (47%) and gastrointestinal issues (28%).
The treatment resulted in a high complete response rate of 88%, with a median progression-free survival of 25.5 months and overall survival of 56.8 months, indicating promising efficacy for this chemotherapy approach.
Utilization of an Alternative Docetaxel-based Intraperitoneal Chemotherapy Regimen in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma: A Continued Need for Ovarian Cancer Patients.Becker, DA., Leath, CA., Walters-Haygood, CL., et al.[2020]
Toxicity of intraperitoneal chemotherapy and risk factors for severe toxicity in optimally debulked ovarian cancer patients.Koo, YJ., Lim, KT.[2019]

References

The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy. [2023]
Intratumoral immunotherapy: using the tumor as the remedy. [2021]
Intratumoural immunotherapies in oncology. [2020]
Delivery routes matter: Safety and efficacy of intratumoral immunotherapy. [2021]
Intratumoral Immunotherapy for Early-stage Solid Tumors. [2021]
Efficacy of mitoxantrone-loaded albumin microspheres for intratumoral chemotherapy of breast cancer. [2019]
Phase II study of cisplatin with irinotecan as induction chemotherapy followed by chemoradiotherapy for unresectable stage III non-small cell lung cancer. [2018]
Utilization of an Alternative Docetaxel-based Intraperitoneal Chemotherapy Regimen in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma: A Continued Need for Ovarian Cancer Patients. [2020]
9.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Toxicity of intraperitoneal chemotherapy and risk factors for severe toxicity in optimally debulked ovarian cancer patients. [2019]