Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Neoplasms

Musculoskeletal Diseases

Mouth and Tooth Diseases

Atrophy

Congenital Abnormalities

Fractures, Bone

Cysts

Bone Cysts

Tooth Loss

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Tooth Diseases

Bone Diseases

Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Bone grafting procedure with investigated medical device

Gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Alexey Y. Drobyshev, MD,PhD,Prof.

The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.

All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

The Clinical Trial of the Safety and Efficacy of the Medical Device "Bone Substitute Based on Octacalcium Phosphate and Biologically Active Nucleic Acids for Bone Tissue Regeneration" (Nucleostim-VEGF)

Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access

To determine the quantity of newly formed bone tissue the following morphometric parameters will be measured on CT scan using special tools ("ROI", region of interest, etc.):

* average density (in HU);
* size (length, width, height) and volume.

All together both measurements allow to determine "bone tissue formation" as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted.

Evaluation of the Adverse Events and Serious Adverse Events frequency

Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Moscow State University of Medicine and Dentistry

Histograft Co., Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Renal Cell

Kidney Neoplasms

Colonic Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Herbal and Botanical

Cyclophosphamide

Hormones

Vaccines

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Cola

Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)

Michael Silverman, MD

The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).

This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies (cancerous growths) of the ovary, breast, colon, or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy. Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles. This is the first time that ZYC300 and Cyclophosphamide will be given together. Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer. In this trial the study drug will be used to boost the immune system. Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells. The T reg cells limit the immune systems attack on infected or abnormal cells. In this study, the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells.

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing

Eisai Inc.

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Immunomodulating Agents

Adjuvants, Immunologic

Therapeutic Classification:

* Noncellular, Therapeutic Cancer Vaccine \> Immunomodulator

Route of Administration:

* Intratumoral injection of cutaneous, subcutaneous or nodal lesions

Mechanism of Action:

* Injection of the IFx-Hu2.0 plasmid DNA construct into the target lesion facilitates the localized expression of the highly immunogenic Emm55 protein by the tumor cells on their cell surface.

Physiological Effect:

* This expression then primes a cascade of immune events that exposes the patient-specific abnormal tumor antigens to the effector mechanisms of the immune system. The immune response becomes systemic as inter-antigenic epitope spreading produces neoantigens to naïve T cells. Therefore, injected lesions are targeted along with non-injected lesions (abscopal effect). This is especially important in conditions where the mutational phenotype varies greatly among individual lesions.

Subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection).

IFx-Hu2.0

Joseph Markowitz, MD, PhD

Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business days for any delayed adverse events.

Six male and/or female adult patients (greater than or equal to 18 years old), of any ethnicity and race, with unresectable stage III or stage IV cutaneous melanoma with accessible lesions, will be eligible for enrollment and treatment with IFx-Hu2.0.

To be eligible for this study, patients with unresectable metastatic disease must have failed, refused or been deemed not candidates for at least one form of systemic anti-PD-1-based immunotherapy as well as BRAF inhibition, if BRAF V600 mutated. Talimogene laherparepvec (IMLYGIC®) is indicated for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Therefore, patients with unresectable cutaneous, subcutaneous, and nodal melanoma lesions recurrent after initial surgery must have failed, refused or been deemed not candidates for talimogene laherparepvec to be eligible for this study.

Enrollees will receive IFx-Hu2.0 at a single time point. Depending on the number of accessible lesions, a patient could receive up to three doses across three lesions (one dose per lesion). Forty milliliters of peripheral blood will be collected from these patients prior to treatment administration and at the follow-up visit four weeks later. The target dose will be 100 μg of plasmid DNA per lesion injected at a final dose volume of 200 μL per lesion. To allow for the observation of any acute toxicity in the first subject enrolled and prevent any occurrence of excessive toxicities in subsequent subjects, the first subject enrolled will receive a single dose of IFx-Hu2.0. Subsequent subjects will be administered the product after at least seven days. Beyond the first subject, the maximum number of lesions to be injected at any given time point in the study phase proposed is three lesions. These samples will be used to perform complete blood counts (CBC) and clinical chemistry tests. A urine sample will be obtained for urinalysis for protein and blood at the same frequency. Blood samples will be drawn for immune response evaluation as well. At the end of the study period, a biopsy of the lesion injected and a non-injected lesion (if applicable) will be collected. If the patient has a response to therapy, the patient will have the option of continuing the study at three-week intervals so long as they have not progressed. Optional tumor biopsies and peripheral blood collections may be obtained on subsequent treatment cycles.

pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma

Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients With Unresectable Stage III or Stage IV Cutaneous Melanoma

Safety was reported using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Feasibility was defined as the ability to treat at least five of the six patients enrolled without drug-related dose-limiting toxicity (DLT).

Evaluation of response rate and assessment of the antitumor immune responses induced by IFx-Hu2.0 per RECIST v1.1 for target lesions.

Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), ≥ 30% decrease in the sum of the longest diameters of target lesions compared with baseline.

Stable Disease (SD), Neither sufficient shrinkage to qualify for partial or complete response (CR or PR) nor sufficient increase to qualify for progressive disease (PD).

Progressive Disease (PD), Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

H. Lee Moffitt Cancer Center and Research Institute

TuHURA Biosciences, Inc.

Therapeutic Classification:

* Noncellular, Therapeutic Cancer Vaccine \> Immunomodulator

Route of Administration:

* Intratumoral injection of cutaneous, subcutaneous or nodal lesions

Mechanism of Action:

* Injection of the IFx-Hu2.0 plasmid DNA construct into the target lesion facilitates the localized expression of the highly immunogenic Emm55 protein by the tumor cells on their cell surface.

Physiological Effect:

* This expression then primes a cascade of immune events that exposes the patient-specific abnormal tumor antigens to the effector mechanisms of the immune system. The immune response becomes systemic as inter-antigenic epitope spreading produces neoantigens to naïve T cells. Therefore, injected lesions are targeted along with non-injected lesions (abscopal effect). This is especially important in conditions where the mutational phenotype varies greatly among individual lesions.

IFx-Hu2.0: Subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection).

IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion/Time Point

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Stage III: tumor no more than 2mm thick and could be ulcerated. Cancer has spread to 1-3 nearby nodes. It has not spread to distant parts of the body.

Stage IIIC: tumor no more than 2mm thick with 1-3 macroscopic node metastases and an ulcerated primary melanoma. Patients with satellite(s)/in-transit metastases, or any patient with nodal disease regardless of ulceration status.

Stage IV: tumor of any thickness and could be ulcerated. Cancer could have spread to nearby nodes. It has spread to distant nodes or to organs.

Note: lesser stages correlate with improved outcomes.

AJCC Clinical Staging

James Bianco, MD - Chief Executive Officer

Participants Analyzed

Serious Adverse Events (SAEs)

Dose Limiting Toxicity (DLT)

The data analysis is described to assess the safety of the injection of the study agent in six patients the intention-to-treat (ITT) approach will be used for response to treatment data analysis of this trial (secondary objective).

Number of Participants With Serious Adverse Events (SAEs) and/or Dose Limiting Toxicities (DLTs)

The intention-to-treat (ITT) approach will be used for response to treatment data analysis of this trial.

Antitumor Response Induced by IFx-Hu2.0 Per RECIST v1.1 for Target Lesions.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing	NCT00381173	Breast Cancer Ovarian Cancer Prostate Cancer Colon Cancer Renal Cancer	Cyclophosphamid...	18 Years -	Eisai Inc.
pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma	NCT03655756	Cutaneous Melan... Cutaneous Melan...	IFx-Hu2.0	18 Years -	TuHURA Biosciences, Inc.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.

Spots Global Cancer Trial Database for plasmid dna

Every month we try and update this database with for plasmid dna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plasmid dna

Every month we try and update this database with for plasmid dna cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plasmid dna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.