Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Vaccines

Lapatinib

Adjuvants, Immunologic

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine.

For each dose of 500µg of dHER2 + AS15 ASCI, two sterile glass vials will be supplied:

* One vial with the lyophilized preparation containing 500 ug of recombinant dHER2 antigen combined with the immunostimulant.
* One vial with liquid adjuvant diluent. The final dHER2 + AS15 ASCI for administration is obtained by reconstitution of the lyophilized preparation with the adjuvant diluents. A dHER2 + AS15 ASCI dose consists of 0.5 ml.

dHER2 + AS15 ASCI

The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.

Michael Morse, MD

This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).

The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a protein that is commonly overexpressed in breast cancer. This protein is combined with the immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal formulation containing three immunostimulatory components.

Lapatinib is FDA approved for use in combination with capecitabine for the treatment of subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.

Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer

A Monocentric, Open-label Phase I/II Study to Assess dHER2+AS15 Cancer Immunotherapeutic Given in Combination With Lapatinib to Patients With ErbB2 Overexpressing Metastatic Breast Cancer Refractory to Trastuzumab

Positive response is defined as an increase in 40 spots over pre-vaccination frequency

Defined as the time from first study treatments administration to documented disease progression or death, and censored at the last date of contact for patients whose disease does not progress. Note: In this definition any progression of lesions will count as "progression".

GlaxoSmithKline

Associate Professor

Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.

dHER2 + AS15 ASCI + Lapatinib

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael Morse

The Safety of dHER2+AS15 ASCI When Administered in Combination With Lapatinib Measured by Occurrence of Severe Toxicities (According to CTCAE, Version 3.0)

ECD-specific T cell response

ICD-specific T cell response

Number of Participants With T-cell Response

Occurrence of Objective Clinical Response (CR or PR) as Best Overall Response.

Time to Progression

Overall Study

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitogens

Antineoplastic Agents, Immunological

HLX22, at four dose levels (3, 10, 25mg/kg), to be intravenously injected once every three weeks; Study drugs given until disease progression, one year of treatment, withdrawal from the study or death

Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody

HLX22

Yanhua Ding

a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care.

This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22.

three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.

Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2

The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).

Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses

the concentration of soluble HER1 and HER2 in serum

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer	NCT00952692	Metastatic Brea...	dHER2 + AS15 AS... Lapatinib	18 Years -	Duke University
Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2	NCT03916094	Solid Tumor	HLX22	18 Years - 75 Years	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for overexpressing her2