Intratumoral IP-001 Injection for Solid Cancers

(INJECTABL-1 Trial)

Not currently recruiting at 17 trial locations

Overseen By Jane Bierman

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Immunophotonics, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Brain tumors, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if IP-001, an experimental treatment, is safe and effective for individuals with certain solid tumors. It targets those with soft tissue sarcoma, non-small cell lung cancer, or colorectal cancer. Participants will first undergo radiofrequency ablation, a procedure that uses heat to destroy cancer cells, followed by an injection of IP-001 directly into the tumor. Individuals with stage 3 or 4 cancer who have not responded to other treatments may be suitable for this trial, particularly if their tumors are smaller and accessible for treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that IP-001 is likely to be safe for humans?

Research has shown that IP-001, when injected into tumors after thermal ablation, was tested in earlier studies with 38 patients. These studies involved individuals with various cancers, including soft tissue sarcoma, non-small cell lung cancer, and colorectal cancer. The results indicated that IP-001 was generally well-tolerated.

Some patients experienced side effects, but most were mild to moderate. Common issues included minor pain and swelling at the injection site. These findings suggest that using IP-001 with thermal ablation is relatively safe. However, as this trial is in an early stage, more research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IP-001 because it offers a novel approach to treating solid cancers like Soft Tissue Sarcoma, Non-Small Cell Lung Cancer, and Colorectal Cancer. Unlike traditional treatments that often involve systemic chemotherapy or targeted therapies, IP-001 is injected directly into the tumor, which may enhance its effectiveness and reduce side effects. This unique delivery method is combined with radiofrequency ablation (RFA), which could potentially increase the tumor's susceptibility to the treatment. By directly targeting the tumor, IP-001 aims to improve treatment outcomes and provide a new hope for patients with these challenging cancers.

What evidence suggests that IP-001 might be an effective treatment for solid cancers?

This trial will evaluate the effectiveness of IP-001 for treating solid tumors, including soft tissue sarcoma, non-small cell lung cancer, and colorectal cancer. Participants will receive radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. Research has shown that IP-001 may enhance the body's immune response to cancer cells when injected directly into the tumor. In earlier studies, patients who received IP-001 after thermal ablation of their tumors showed positive initial responses. Early results suggest it could be particularly beneficial for individuals who haven't responded to standard treatments like chemotherapy. While further research is needed, these early findings offer promise for those considering joining this trial. ^{1 3 6 7 8}

Who Is on the Research Team?

Markus Jorger, MD

Principal Investigator

Cantonal Hospital of St. Gallen

Diane Beatty, PhD

Principal Investigator

Immunophotonics, Inc.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive radiofrequency ablation followed by an intratumoral injection of IP-001. Treatment can occur every 6 weeks for up to 4 cycles.

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up visits occur every 6 weeks for 5 visits.

30 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IP-001

Trial Overview 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.

How Is the Trial Designed?

Group I: Soft Tissue Sarcoma (STS) Experimental Treatment 1 Intervention

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

Group II: Non-Small Cell Lung Cancer (NSCLC) Experimental Treatment 1 Intervention

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

Group III: Colorectal Cancer (CRC) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Immunophotonics, Inc.

Lead Sponsor

Trials

3

Recruited

210+

Published Research Related to This Trial

Intraperitoneal (IP) chemotherapy for epithelial ovarian cancer showed a high completion rate (80.5% completed at least six cycles) despite a significant incidence of severe toxicity (Grade 3 or 4 in 73.2% of patients).

The study suggests that while IP chemotherapy can be effective, especially after optimal debulking surgery, careful monitoring for toxicity is essential, particularly in patients who have undergone neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity of intraperitoneal chemotherapy and risk factors for severe toxicity in optimally debulked ovarian cancer patients. Koo, YJ., Lim, KT.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery routes matter: Safety and efficacy of intratumoral immunotherapy. De Lombaerde, E., De Wever, O., De Geest, BG.[2021]

Intratumoral immunotherapy is a promising approach that enhances the effectiveness of cancer treatments by directly delivering immune-activating therapies into tumors, which helps overcome the immunosuppressive environment that often limits systemic therapies.

Effective delivery of these therapies into the tumor is crucial for their success, and the review discusses various minimally invasive delivery devices that can improve the administration of intratumoral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy. Brito-Orama, S., Sheth, RA.[2023]

Intratumoral delivery of immunotherapy is a promising strategy for treating early-stage solid tumors, as it minimizes severe side effects associated with systemic delivery while enhancing local tumor-specific immunity.

Over 20 ongoing neoadjuvant clinical trials are exploring various intratumoral immune stimulatory agents, indicating a strong interest in optimizing this approach for effective cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratumoral Immunotherapy for Early-stage Solid Tumors. Hong, WX., Haebe, S., Lee, AS., et al.[2021]

Intratumoural therapies, which involve directly injecting treatments into tumors, show promise in transforming 'cold' tumor microenvironments into 'hot' ones that can better respond to immune checkpoint inhibitors, potentially improving patient outcomes.

Melanoma has been the primary focus for these therapies due to its immunogenic nature, but advancements are enabling the application of intratumoural treatments to other cancer types, supported by improved injection techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratumoural immunotherapies in oncology. Xu, W., Atkinson, VG., Menzies, AM.[2020]

The combination of cisplatin and irinotecan as induction chemotherapy followed by chemoradiotherapy did not show sufficient anti-tumor activity, with an overall response rate of only 45%, which was below the threshold for efficacy.

The treatment was associated with significant toxicity, including neutropenia, diarrhea, and fatigue, leading to the conclusion that the regimen was poorly tolerated and did not provide a clinical benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Intratumoral injection of mitoxantrone using albumin microspheres significantly enhances localized drug delivery, leading to improved survival rates in a murine breast cancer model.

This method reduces systemic toxicity compared to traditional intravenous chemotherapy, demonstrating a safer and more effective approach to cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mitoxantrone-loaded albumin microspheres for intratumoral chemotherapy of breast cancer. Almond, BA., Hadba, AR., Freeman, ST., et al.[2019]

Immune checkpoint inhibitors targeting PD-1, PD-L1, and CTLA-4 have improved survival rates in cancer patients by enhancing the immune response against tumors, but only a small percentage of patients experience long-term benefits and these treatments can cause severe autoimmune side effects.

Intratumoral immunotherapy, which involves injecting immunostimulatory agents directly into tumors, can achieve high local drug concentrations while minimizing systemic toxicity, potentially allowing for more effective and safer cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratumoral immunotherapy: using the tumor as the remedy. Marabelle, A., Tselikas, L., de Baere, T., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05688280

NCT05688280 | Intratumoral Injection of IP-001 Following ... 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 ...

2. humanforschung-schweiz.ch humanforschung-schweiz.ch/en/trial-search/study-detail/61013/translate/en/?cHash=82c5ee8c5b5f596aa855e38e0eb00574

Intratumoral injection of IP-001 after thermal ablation in ... This study investigates the safety and initial efficacy of an immunostimulatory thermal ablation combined with the investigational product IP- ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06630624/dose-finding-efficacy-and-immunological-response-of-ip-001-following-mwa-or-ire-for-crlm

Dose Finding, Efficacy and Immunological Response of IP ... The primary objectives of this phase I/II, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological ...

4. data.niaid.nih.gov data.niaid.nih.gov/resources?id=5280

Intratumoral Injection of IP-001 Following Thermal Ablation ... 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 ...

5. trialx.com trialx.com/clinical-trials/listings/306903/dose-finding-efficacy-and-immunological-response-of-ip-001-following-mwa-or-ire-for-crlm/

Dose Finding, Efficacy and Immunological Response of IP-001 ... In phase 2 part 2, a randomized, two-armed study assesses the efficacy and immunomodulation of IP-001 following two ablative modalities: arm A (MWA) and arm C ( ...

6. isrctn.com isrctn.com/ISRCTN16103145

Injection of IP-001 into thermally ablated solid tumors The safety data below are from previous clinical studies where a total of 38 patients took the study drug with one of two types of thermal ablation. The ...

7. humanforschung-schweiz.ch humanforschung-schweiz.ch/de/studiensuche/studien-detail/61013/translate/en/?cHash=82c5ee8c5b5f596aa855e38e0eb00574

Intratumoral injection of IP-001 after thermal ablation in ... The intratumoral injection of IP-001 administered directly into the previously treated tumor after thermal ablation is also intended to further ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06630624

Study Details | NCT06630624 | Dose Finding, Efficacy and ... The purpose of this trial is to assess the optimal dose, efficacy, safety and immunological effect intra-tumoral injection of IP-001 following ablation. The ...