Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Milatuzumab will be given at a starting dose of 120 mg/m2, and then if no response or significant toxicity is seen after a total of 12 weeks, the dose will be gradually increased, by 120 mg/ m2 every four weeks, for a total of another 12 weeks.

Milatuzumab

Michal Z Haran, MD

Lev Shvidel, MD

Michal Haran, MD

The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.

The aim of this study is to determine whether the anti-CD74 monoclonal antibody Milatuzumab provides benefit to subjects with CLL in advanced stage or progressive disease. The primary objectives of this study are to assess response rate to the agent, as well as the safety in CLL, using different doses: Overall response (OR), complete response (CR) and partial response (PR) will be determinate according to the NCI criteria.

The secondary objectives are to determine: duration of response, time to progression, overall survival, and the range of doses in which efficacy is seen and MTD not reached.

This study will be done in parallel with other phase I-II studies conducted by Immunomedics.

The study design will take into account that the high levels of circulating CD74expressing cells in CLL may affect both the acute (although probably not long term) toxicity and the efficacy of the study medication. This could translate to a different MTD and a different cumulative dose of Milatuzumab, needed to achieve response.(either a higher dose or longer treatment period.).

The study will be divided into two treatment phases. In the first phase we aim to address whether the dose of 120 mg/m2 is effective in CLL, and also if it is safe. In the second phase we will assess the safety and possible efficacy of higher doses, in those patients that did not achieve a significant response in the first phase. This will be done by gradual dose escalations, not to exceed 600 mg, or the MTD reached in other studies.

In addition, the study will aim at gaining further understanding of the effect of Milatuzumab on the biological in-vitro function of CLL cells.

The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

Phase I-II Trial of the Anti CD74 Monoclonal Antibody-Milatuzumab as a Single Agent in Refractory Chronic Lymphocytic Leukemia

Gilead Sciences

Kaplan Medical Center

Dr. Michal Haran

Digestive System Diseases

Gland and Hormone Related Diseases

Carcinoma

Pancreatic Neoplasms

Carcinoma, Transitional Cell

Pancreatic Cancer

Transitional Cell Carcinoma

Dose Escalation(Standard 3+3 Dose escalation) Cohort 1: 5 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days.

Cohort 2: 10 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days.

Cohort 3: 15 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days.

Dose Expansion Within the MTD and sub-MTD dose groups, select 1-2 doses for dose expansion, including approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase. Conduct safety, tolerability, and preliminary anti-tumor efficacy evaluations to provide a basis for the recommended phase II clinical dose (RP2D). PK studies will be conducted on 12 subjects in each dose group, including dose escalation trial cases.

Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle

HY-0102

Dingwei Ye, PhD

Jian Zhang, PhD

Jian Zhang

Dingwei Ye

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of HY-0102 administered intravenously (IV) once every two weeks in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of patients with advanced solid tumors.

This is a Phase I trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors (urothelial carcinoma, colorectal and pancreatic cancers, etc).

Three dosing cohorts are planned with the doses of 5, 10 and 15 mg/kg. The study will apply a standard 3+3 dose escalation design in dose escalation.Dose expansion will enroll approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase.

The number of enrolled patients is estimated to be up to 50. The dose limiting toxicity evaluation period will be the first 28 days (Cycle 1) and subsequent cycles will be 4 weeks in duration. Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation. HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond.

A Study of HY-0102 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors

To assess by the occurrence of Drug Limited Toxicities (DLTs)

To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

The overall response rate (ORR) will be estimated based on the proportion of evaluable patients whose overall response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1

According to the RECIST v1.1 to assess anti-tumor activity of HY-0102

Cmax of HY-0102 is observed directly from data

Ctrough of HY-0102 was observed directly from data.

Tmax of HY-0102 was observed directly from data as time of Cmax.

AUClast of HY-0102 was determined by linear/log trapezoidal method.

AUCtau of HY-0102 was determined using linear/log trapezoidal method.

AUCinf = AUClast + (Clast\*/kel), where Clast\* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.

T1/2 of HY-0102 was observed directly from data.

Shanghai YingLi Pharmaceutical Co. Ltd.

Recurrence

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Anti-Infective Agents

Bevacizumab

Vaccines

Poly ICLC

Endothelial Growth Factors

Mitogens

Monatide (IMS 3015)

Adjuvants, Immunologic

Keyhole-limpet hemocyanin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Interferons

Immunologic Factors

Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.

Vaccine of long synthetic peptides encoding T cell epitopes in tumor associated antigens.

Vaccine Consists of:

EGFRvIII peptide 100 mcg IL13Ralpha peptide 100 mcg EphA2 peptide 100 mcg Her2/neu peptide 100 mcg YKL-40 peptide 100 mcg

Peptide Vaccine

Poly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.

Poly-ICLC as immune adjuvant

Potent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases

Keyhole limpet hemocyanin (KLH)

Sharon Gardner, MD

This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and bevacizumab in adults with recurrent glioblastoma.

All patients will receive the same dose of vaccine, Poly-ICLC and bevacizumab. The therapy consists of 3 blocks. During the first block, patients will receive bevacizumab every 2 weeks for 2 doses. During block 2, patients will receive vaccine + Poly-ICLC + bevacizumab on weeks 1, 3, 5 and 7. An MRI will be performed after week 7 therapy. If there is no significant progression, then the patients will continue with block 3. During block 3, therapy consists of vaccine + Poly-ICLC monthly and bevacizumab every 2 weeks for 10 months. Keyhole limpet hemocyanin (KLH) will be given as a positive control with the first vaccine. Immune studies will be performed in all patients enrolled in this study.

A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma

Measured either ex-vivo (assayed directly from thawed PBMCs) or following in-vitro pre-sensitization.

MOUNT SINAI HOSPITAL

NYU Langone Health

Lymphoma

Lymphoma, Non-Hodgkin

Lymphosarcoma

Antirheumatic Agents

Rituximab

All subjects will receive weekly intravenous infusions of AME-133v. Each subject will receive a total of 4 infusions administered once a week for 3 consecutive weeks.

AME-133v (LY2469298)

Brian Link, MD

Andres Forero-Torres, MD

Nam Dang, MD

Sven de Vos, MD, PhD

Kristen Ganjoo, MD

Brad Pohlman, MD

Mitchell R. Smith, MD, PhD

Michael E. Williams, MD

Ian Flinn, MD, PhD

Markus Mapara, MD, PhD

Stephanie A. Gregory, MD

This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.

The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody.

Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma

Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)	NCT00868478	Chronic Lymphoc...	Milatuzumab	18 Years - 80 Years	Kaplan Medical Center
A Study of HY-0102 in Patients With Advanced Solid Tumors	NCT06094777	Advanced Solid ...	HY-0102	18 Years -	Shanghai YingLi Pharmaceutical Co. Ltd.
A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma	NCT02754362	Glioblastoma Glioma	Bevacizumab Peptide Vaccine Poly-ICLC as im... Keyhole limpet ...	18 Years -	NYU Langone Health
Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma	NCT00354926	Non-Hodgkin's L...	AME-133v (LY246...	18 Years -	Applied Molecular Evolution

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