Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Carcinoma

Urinary Bladder Neoplasms

Virus Diseases

Adenoviridae Infections

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

BCG Vaccine

Molgramostim

Sargramostim

Immunologic Factors

oncolytic virus genetically modified to express GM-CSF

Treatment once weekly by intravesical route. Use of DDM to first remove the GAG layer of the bladder and to improve virus transduction. Installation of 100 ml. of CG0070 at 10e12 viral particles for 45 minutes inside bladder.

oncolytic adenovirus expressing GMCSF

This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need. For the present study, Cis or Cis with Ta and/or T1 patients can only be enrolled if they have failed the BOND study and are medically unfit for surgery. Furthermore, patients with high grade Ta or T1 disease who have failed both BCG and chemotherapy treatments are also prone to disease progression. Since these patients are not eligible to be enrolled in the BOND trial, the present study will serve as an alternative to access CG0070 experimental treatment.

Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer

Phase II Safety and Efficacy Study of CG0070 Oncolytic Vector Regimen in Patients With High Grade Non-Muscle Invasive Bladder Carcinoma Disease (NMIBC) Who Have Failed BCG and Refused Cystectomy

CG Oncology, Inc.

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Vaccinia

Communicable Diseases

Poxviridae Infections

DNA Virus Infections

Double Recombinant Vaccinia Virus VV-GMCSF-Lact

Intratumoral injections:

1\*107 PFU (calculated at minimal ED on mice); 2\*107 PFU; 4\*107 PFU; 6\*107 PFU; 8\*107 PFU; 10\*107 PFU;

Elena V. Kuligina, PhD

Vera S. Berezina, PhD

Petr V. Krivorotko, Professor

Purpose of the study is to evaluate the safety, tolerability and pharmacokinetic parameters of the drug based on double recombinant vaccinia virus VV-GMCSF-Lact, in patients with recurrent/refractory metastatic breast cancer in successive cohorts with dose escalation with single and multiple administration.

The study provides: determination of the maximum tolerated dose of the drug and the frequency, nature, intensity and duration of adverse events connected with the use of the study drug in escalating doses; detection of dose-limiting toxicity, its severity, duration and reversibility; determination of the profile of virus pharmacokinetics and antivirus antibodies; assessment of the objective response to the treatment.

Stage 1,: The virus drug is administered intratumorally once according to a "3+3" design in the dosage from 1\*107 PFU to 10\*107 PFU. The frequency of dose-limiting toxicity (DLT) will be evaluated (non-hematological toxicity III degree and above; development of febrile neutropenia and body temperature \> 38.3°C more than two days after drug administration; thrombocytopenia III degree and above and/or hemorrhagic complications; repeated increase in ALT and/or AST activity is more than 4 times higher than the normal upper limit).

Escalation to the next level occurs if there is no DLT in the entire cohort under study. The study stops if the incidence of DLT in a cohort of 3 patients is 2 or 3. The maximum tolerated dose (MTD) will be considered the studied dose that is lower than the dose which DLT was determined. Stage 1 assumes randomization of no more than 36 patients.

Stage 2, multiple administration: According to Stage 1 the study will move to the second stage if there will be possibility to study at least one dosage regimen based on the previously studied dose. At Stage 2 two doses in ascending order below the MTD and MTD are planned to be used. Escalation to the next level occurs if no DLT is observed during dosing of the first three patients. If DLT develops and drug administration is discontinued, the patient is not excluded from the study, her drug administration visits are skipped, and she goes through all follow-up visits. The drug will be administered intratumorally 1 time per week for 4 weeks in 3 dosages: MTD and 2 lower dosages. Each cohort will include up to 6 patients in a "3+3" design. It is expected to include up to 24 patients, taking into account the possible inclusion of patients to replace those who left.

Open Multi-cohort Study of Safety and Tolerability

Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact

Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact in Patients With Recurrent/Refractory Metastatic Breast Cancer With Single and Multiple Administration

Determination of the antivirus antibodies titer in the blood after 7, 14, 21, 28 days after intratumoral administration.

Assessment of Objective response (stabilization / progression rate) to treatment on the RECIST 1.1 scale.

Evaluation of tumor size according to the results of CT.

The severity of adverse events will be assessed according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0. National Cancer Institute. 2017.

Degree of severity, duration and reversibility of dose-limiting toxicity will be detected

Determination of virus concentrations in blood after 5, 15, 30 minutes, 1, 3, 6, 12, 24, 48, 72, 120, 168 and 216 hours after intratumoral administration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer	NCT02143804	Bladder Cancer High Grade Non Muscle Inva...	oncolytic adeno...	18 Years -	CG Oncology, Inc.
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer	NCT02143804	Bladder Cancer High Grade Non Muscle Inva...	oncolytic adeno...	18 Years -	CG Oncology, Inc.
Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact	NCT05376527	Oncolytic Virot...	Double Recombin...	18 Years -	"Oncostar" LLC

Spots Global Cancer Trial Database for gmcsf

Every month we try and update this database with for gmcsf 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 gmcsf

Every month we try and update this database with for gmcsf 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 gmcsf 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.