Patients receive entolimod IM or SC on days 1, 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

entolimod

pharmacological study

laboratory biomarker analysis

Alex Adjei

This phase I trial studies the side effects and best dose of entolimod in treating patients with locally advanced or metastatic solid tumors that cannot be removed by surgery. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing.

PRIMARY OBJECTIVES:

I. To determine the safety, tolerability, and maximum tolerated dose (MTD) of CBLB502 (entolimod) in patients with advanced cancers.

SECONDARY OBJECTIVES:

I. To assess any preliminary evidence of efficacy with the CBLB502 in patients with advanced cancers.

II. To evaluate pharmacokinetic (PK)/pharmacodynamic (PD) profiles of CBLB502 in patients with advanced cancers.

III. To characterize the effect, if any, of intramuscular or subcutaneous CBLB502 on QTcB.

TERTIARY OBJECTIVES:

I. To correlate pre-treatment tissue expression of toll-like receptor 5 (TLR5) with clinical activity (Response Evaluation Criteria In Solid Tumors \[RECIST\] tumor response) and PD response (as measured by cytokine levels) of CBLB502.

OUTLINE: This is a dose-escalation study.

Patients receive entolimod intramuscularly (IM) on day 1 and subcutaneously (SC) on days 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery

A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profile of CBLB502 in Patients With Advanced Cancers

Evaluated using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

ORR will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. Tumor response will be summarized, and the 95% confidence interval for ORR (complete response \[CR\] + partial response \[PR\]) will be presented. Evaluated using the RECIST criteria.

Cleveland BioLabs, Inc.

Roswell Park Cancer Institute

Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Nasopharyngeal Carcinoma

Mucositis

Laryngeal Diseases

Carcinoma, Verrucous

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Paranasal Sinus Neoplasms

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Pharyngeal Neoplasms

Pharyngeal Diseases

Nasopharyngeal Neoplasms

Nasopharyngeal Diseases

Nose Neoplasms

Nose Diseases

Paranasal Sinus Diseases

Mouth Neoplasms

Tongue Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Tongue Cancer

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Patients undergo IMRT 5 times per week for 7 weeks, receive cisplatin IV once weekly for 7 weeks, and entolimod SC on days 1, 8, 15, 22, 29, 36, and 43.

intensity-modulated radiation therapy

cisplatin

Anurag Singh

This phase I trial studies the side effects and best dose of entolimod in treating patients with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing. Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entolimod together with cisplatin and radiation therapy may kill more tumor cells

PRIMARY OBJECTIVES:

I. To define the Phase II dose of CBLB502 (entolimod) when given as weekly injections during irradiation with cisplatin, for patients with poor prognosis advanced squamous cell carcinomas of the head and neck receiving chemoradiotherapy.

SECONDARY OBJECTIVES:

I. To describe the adverse event (AE) profile and the dose limiting toxicities of CBLB502 when administered weekly in combination with cisplatin and radiation therapy.

II. To determine the maximally tolerated dose (if observed) of CBLB502 in combination with cisplatin and radiation therapy.

III. To describe the pharmacokinetics (PK) of CBLB502 when administered in combination with cisplatin.

IV. To describe the pharmacodynamics (PD) of CBLC502 by examining plasma levels of various cytokines, including filgrastim (granulocyte-colony stimulating factor \[G-CSF\]), interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-alpha (TNF-α).

V. To describe any clinical activity of CBLB502 in the form of mitigation of mucositis.

VI. To describe the response rate to chemoradiotherapy in combination with CBLB502.

OUTLINE: This is a dose-escalation study of entolimod.

Patients undergo intensity-modulated radiation therapy (IMRT) 5 times per week for 7 weeks, receive cisplatin intravenously (IV) once weekly for 7 weeks, and entolimod subcutaneously (SC) on days 1, 8, 15, 22, 29, 36, and 43.

After completion of study treatment, patients are followed up for 3 months.

Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy

A Phase I Study of CBLB502 in the Treatment of Patients With Poor Prognosis Advanced Squamous Cell Carcinomas of the Head and Neck Receiving Chemoradiotherapy

Summarized descriptively by time point (mean, standard deviation). All safety analyses will be presented by dose cohort and overall as well as examined for relation to demographic parameters (i.e., gender, weight, body surface area \[BSA\]) and covariance or dependence on PK, PD, or presence of anti-entolimod antibodies at baseline and/or the development of entolimod antibodies.

A population PK model will be developed utilizing the PK time points collected and used to estimate individual areas under the curve (AUCs) or clearance (CL) of entolimod. The effect of patient factors, such as demographics and ECOG status, on entolimod PK will be evaluated by the model to help explain the interpatient variability in PK. Entolimod AUC, as well as the observed Crnax, will then be tested for association changes in cytokine levels, such as G-CSF, IL-6, IL-8, IL- 10 and TNF-alpha.

The percentage of patients with mucositis will be tabulated overall and by dose level.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery	NCT01527136	Unspecified Adu...	entolimod pharmacological... laboratory biom...	18 Years -	Roswell Park Cancer Institute
Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy	NCT01728480	Mucositis Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Verru... Recurrent Verru... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Verru... Stage III Verru... Stage IV Squamo... Stage IV Squamo... Stage IVA Squam... Stage IVA Squam... Stage IVA Squam... Stage IVA Squam... Stage IVA Verru... Stage IVA Verru... Stage IVB Squam... Stage IVB Squam... Stage IVB Squam... Stage IVB Squam... Stage IVB Verru... Stage IVB Verru... Stage IVC Squam... Stage IVC Squam... Stage IVC Squam... Stage IVC Squam... Stage IVC Verru... Stage IVC Verru... Tongue Cancer	entolimod intensity-modul... cisplatin pharmacological... laboratory biom...	18 Years -	Roswell Park Cancer Institute
Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy	NCT01728480	Mucositis Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Verru... Recurrent Verru... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Verru... Stage III Verru... Stage IV Squamo... Stage IV Squamo... Stage IVA Squam... Stage IVA Squam... Stage IVA Squam... Stage IVA Squam... Stage IVA Verru... Stage IVA Verru... Stage IVB Squam... Stage IVB Squam... Stage IVB Squam... Stage IVB Squam... Stage IVB Verru... Stage IVB Verru... Stage IVC Squam... Stage IVC Squam... Stage IVC Squam... Stage IVC Squam... Stage IVC Verru... Stage IVC Verru... Tongue Cancer	entolimod intensity-modul... cisplatin pharmacological... laboratory biom...	18 Years -	Roswell Park Cancer Institute
Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery	NCT01527136	Unspecified Adu...	entolimod pharmacological... laboratory biom...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for entolimod

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

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