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
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.
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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.
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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
References
The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy. [2023]Systemically administered immunotherapies have revolutionized the care of patients with cancer; however, for many cancer types, most patients do not exhibit objective responses. Intratumoral immunotherapy is a burgeoning strategy that is designed to boost the effectiveness of cancer immunotherapies across the spectrum of malignancies. By locally administering immune-activating therapies into the tumor itself, immunosuppressive barriers in the tumor microenvironment can be broken. Moreover, therapies too potent for systemic delivery can be safely administered to target location to maximize efficacy and minimize toxicity. In order for these therapies to be effective, though, they must be effectively delivered into the target tumor lesion. In this review, we summarize the current landscape of intratumoral immunotherapies and highlight key concepts that influence intratumoral delivery, and by extension, efficacy. We also provide an overview of the breadth and depth of approved minimally invasive delivery devices that can be considered to improve delivery of intratumoral therapies.
Intratumoral immunotherapy: using the tumor as the remedy. [2021]Immune checkpoint-targeted monoclonal antibodies directed at Programmed Death Receptor 1 (PD-1), Programmed Death Ligand 1 (PD-L1) and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4) are currently revolutionizing the prognosis of many cancers. By blocking co-inhibitory receptors expressed by antitumor T cells, these antibodies can break the immune tolerance against tumor cells and allow the generation of durable cancer immunity. Benefits in overall survival over conventional therapies have been demonstrated for patients treated with these immunotherapies, leading to multiple approvals of such therapies by regulatory authorities. However, only a minority of patients develop an objective tumor response with long-term survival benefits. Moreover, the systemic delivery of immunotherapies can be responsible for severe auto-immune toxicities. This risk increases dramatically with anti-PD(L)1 and anti-CTLA-4 combinations and currently hampers the development of triple combination immunotherapies. In addition, the price of these novel treatments is probably too high to be reimbursed by health insurances for all the potential indications where immunotherapy has shown activity (i.e. in more than 30 different cancer types). Intratumoral immunotherapy is a therapeutic strategy which aims to use the tumor as its own vaccine. Upon direct injections into the tumor, a high concentration of immunostimulatory products can be achieved in situ, while using small amounts of drugs. Local delivery of immunotherapies allows multiple combination therapies, while preventing significant systemic exposure and off-target toxicities. Despite being uncertain of the dominant epitopes of a given cancer, one can therefore trigger an immune response against the relevant neo-antigens or tumor-associated antigens without the need for their characterization. Such immune stimulation can induce a strong priming of the cancer immunity locally while generating systemic (abscopal) tumor responses, thanks to the circulation of properly activated antitumor immune cells. While addressing many of the current limitations of cancer immunotherapy development, intratumoral immunotherapy also offers a unique opportunity to better understand the dynamics of cancer immunity by allowing sequential and multifocal biopsies at every tumor injection.
Intratumoural immunotherapies in oncology. [2020]Although immune checkpoint inhibitors have become the standard of care for many tumours, the majority of patients fail to achieve sustained benefit, often owing to the lack of a T-cell inflamed tumour microenvironment (TME). Directly injected intratumoural therapies present a potential strategy to induce T-cell inflammation and convert a 'cold' immune-inert TME into a 'hot' immune-inflamed TME. Various approaches including chemoablation, oncolytic viral therapy, cytokines and agents targeting innate immunity such as Toll-like receptor agonists and stimulator of interferon genes agonists are in clinical development. Thus far, melanoma has led the way in intratumoural drug development owing to its relative immunogenicity and propensity for cutaneous metastasis easily amenable to injections. However, intratumoural therapies are moving to other tumour types and advances in endoscopic and interventional radiological techniques are allowing these agents to be injected into visceral lesions. This review provides an overview of the current status of intratumoural therapies in oncology, as well as future directions regarding therapeutic niches and appropriate trial design for intratumoural agents.
Delivery routes matter: Safety and efficacy of intratumoral immunotherapy. [2021]Many anticancer immunotherapeutic agents, including the monoclonal immune checkpoint blocking antibodies, toll-like receptor (TLR) agonists, cytokines and immunostimulatory mRNA are commonly administrated by the intravenous route. Unfortunately, this route is prone to inducing, often life-threatening, side effects through accumulation of these immunotherapeutic agents at off-target tissues. Moreover, additional biological barriers need to be overcome before reaching the tumor microenvironment. By contrast, direct intratumoral injection allows for accomplishing local immune activation and multiple (pre)clinical studies have demonstrated decreased systemic toxicity, improved efficacy as well as abscopal effects. The approval of the oncolytic herpes simplex virus type 1 talimogene laherparepvec (T-VEC) as first approved intratumoral oncolytic virotherapy has fueled the interest to study intensively other immunotherapeutic approaches in preclinical models as well as in clinical context. Moreover, it has been shown that intratumoral administration of immunostimulatory agents successfully synergizes with immune checkpoint inhibitor therapy. Here we review the current state of the art in (pre)clinical intratumoral immunotherapy.
Intratumoral Immunotherapy for Early-stage Solid Tumors. [2021]The unprecedented benefits of immunotherapy in advanced malignancies have resulted in increased interests in exploiting immune stimulatory agents in earlier-stage solid tumors in the neoadjuvant setting. However, systemic delivery of immunotherapies may cause severe immune-related side-effects and hamper the development of combination treatments. Intratumoral delivery of neoadjuvant immunotherapy provides a promising strategy in harnessing the power of immunotherapy while minimizing off-target toxicities. The direct injection of immune stimulating agents into the tumor primes the local tumor-specific immunity to generate a systemic, durable clinical response. Intratumoral immunotherapy is a highly active area of investigation resulting in a plethora of agents, for example, immune receptor agonists, non-oncolytic and oncolytic viral therapies, being tested in preclinical and clinical settings. Currently, more than 20 neoadjuvant clinical trials exploring distinct intratumoral immune stimulatory agents and their combinations are ongoing. Practical considerations, including appropriate timing and optimal local delivery of immune stimulatory agents play an important role in safety and efficacy of this approach. Here, we discuss promising approaches in drug delivery technologies and opportunity for combining intratumoral immunotherapy with other cancer treatments and summarize the recent preclinical and clinical evidences that highlighted its promise as a part of routine oncologic care.
Efficacy of mitoxantrone-loaded albumin microspheres for intratumoral chemotherapy of breast cancer. [2019]Systemic toxicity of intravenously delivered chemotherapy is a limiting factor in the treatment of many cancers. We have shown that intratumoral injection of antineoplastic drugs can provide high localized drug concentrations with greatly reduced systemic toxicity. Using albumin microspheres as a drug carrier, localized and sustained release of chemotherapeutic drugs has been achieved by intratumoral injection, thus increasing the intratumoral dose and antitumor efficacy. Microspheres provide the advantages of localized, prolonged drug release. The efficacy and toxicity of intratumoral free mitoxantrone or mitoxantrone-loaded albumin microspheres were evaluated in a murine breast cancer model. In the same model, a combination of these two therapies was also evaluated. Results indicated that intratumoral mitoxantrone, especially in microsphere preparations, significantly improved survival and decreased systemic toxicity.
Phase II study of cisplatin with irinotecan as induction chemotherapy followed by chemoradiotherapy for unresectable stage III non-small cell lung cancer. [2018]We evaluated the anti-tumor activity and safety of cisplatin with irinotecan (IP) induction chemotherapy followed by chemoradiotherapy with etoposide/cisplatin (EP).
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]The objective of this study was to report the tolerability and toxicity of a regimen consisting of intravenous (IV) docetaxel and intraperitoneal (IP) cisplatin and paclitaxel with granulocyte colony-stimulating factor support.
Toxicity of intraperitoneal chemotherapy and risk factors for severe toxicity in optimally debulked ovarian cancer patients. [2019]To assess the effect and toxicity of intraperitoneal (IP) chemotherapy for epithelial ovarian cancer and to determine the risk factors for severe toxicity.