Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients will receive weekly intravenous doses of 20 mg/m2 of the antibody Hu3S193. The infusion will take 60 ± 10 minutes. The antibody should be diluted in 500 mL of normal saline.

Hu3S193

PAULO MG HOFF, MD Professor

SERGIO V SERRANO, MD

The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer. The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.

This is a national study, open label, single arm, phase II study which will be conducted in seven centers in Brazil. The study will be coordinated by the INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO in collaboration with RECEPTA Biopharma. The study is funded by the CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO (CNPq). Before any procedure relating to the study, patients must read and sign the informed consent (IC). The inclusion of patients begin immediately after regulatory approval and is expected to end after reaching the number of patients. The follow-up term will last at least 24 months for each patient included, unless limited by death, loss to follow up or withdrawal of informed consent. A total of 60 patients will be recruited in this study. The eligible patients must be 18 or older, confirmed diagnosis of breast cancer with locally advanced or metastatic progression after one or two lines of previous hormone treatment, confirmation of Lewis antigen expression -as assessed by central laboratory, measurable or evaluable disease and adequate organ function. Patients will receive weekly intravenous doses of the antibody Hu3S193 until disease progression, unacceptable toxicity, withdrawal of consent or the investigator's decision, whichever occurs first. The study's primary endpoint is the clinical benefit rate.

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy

A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy

The primary efficacy analysis will be done through the clinical benefit rate, as defined by the proportion of patients achieving best response, complete response, partial response or stable disease for more than 24 weeks

from inclusion until disease progression or death

From patient inclusion until disease progression or death - evaluated radiologically by CT

Fundação Faculdade de Medicina

Recepta Biopharma

Instituto do Cancer do Estado de São Paulo

FACP MD PhD, Full Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

hu3S193

Oren Smaletz, MD

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

OBJECTIVES:

Primary

* To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria (Response Evaluation Criteria in Solid Tumors).

Secondary

* To determine the safety of the study drug.
* To determine the drug pharmacokinetics when administered in multiple weekly injections.

Exploratory analysis

* Clinical Benefit (objective response rate + tumor stabilization).
* Progression Free Survival (PFS).
* Duration of Response.
* Overall Survival.
* 12-month survival rate.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly.

Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER

The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.

Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.

The evaluation of target and non-target lesions is described at the Outcome Measure titled "Best Overall Response". CR: Complete Response; PR: Partial Response; SD: Stable Disease.

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.

Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.

Rate of patients alive 12 months after starting therapy with the investigational product.

Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).

Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

A listing of all adverse events is located in the Reported Adverse Event module.

Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.

Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.

hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

Age, Categorical

Sex: Female, Male

Brazil

Region of Enrollment

Positive (+1)

Positive (+2)

Positive (+3)

Positive (+4)

Expression of Lewis Y was investigated by immunohistochemistry on primary or metastatic tumor biopsies. To determine Lewis Y expression levels, a semi-quantitative approach was used, which considered cytoplasm and membrane compartments independently. The score taken into account was from the higher expression observed, either cytoplasm or membrane.

Participants with positive expression of Lewis Y in tumor were scored, according to the percentage of positively stained cells, into the following categories: +4 (\>75% positive cells); +3 (51 to 75%); +2 (26 to 50%); and +1 (1 to 25%).

Expression of the Lewis Y antigen in tumor tissue

Type A

Type B

Type AB

Type O

ABO blood type

The baseline descriptive analyses were performed for the safety population. Lewis Y antigen expression and blood type were also analyzed for this population.

Dr. Oren Smaletz, M.D., Medical Director

Complete response

Partial response

Stable disease

Disease progression

Unknown

All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.

Best Overall Response

Adverse Events

Serious Adverse Events

All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.

Number of Participants With Adverse Events and Serious Adverse Events

Adverse event: Nausea

Adverse event: Fatigue

Adverse event: Diarrhoea

Adverse event: Hypersensitivity

Adverse event: Hypertension

Adverse event: Pyrexia

Adverse event: Constipation

Adverse event: Dry mouth

Adverse event: Haemoglobin abnormal

Adverse event: Tremor

Adverse event: Urticaria

Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).

Mean Cmax of Hu3S193

Mean Cmin of Hu3S193

All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.

Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.

All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.

Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses

All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.

Clinical Benefit

Progression Free Survival (PFS)

Overall Survival

12-Month Survival Rate

PFS in patients with ascites at baseline (n=9)

PFS in patients without ascites at baseline (n=17)

Progression Free Survival in Patients With and Without Ascites at Baseline

PFS in patients with visceral disease (n=5)

PFS in patients without visceral disease (n=20)

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression

All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.

Progression Free Survival in Patients With and Without Visceral Disease at Baseline

Without ascites and no visceral disease (n=13)

With ascites and/or visceral disease (n=12)

All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.

Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline

Spots Global Cancer Trial Database for hu3s193

Every month we try and update this database with for hu3s193 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo
Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer	NCT00617773	Fallopian Tube ... Ovarian Cancer Primary Periton...	hu3S193	18 Years -	Recepta Biopharma
Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer	NCT00617773	Fallopian Tube ... Ovarian Cancer Primary Periton...	hu3S193	18 Years -	Recepta Biopharma
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for hu3s193

Every month we try and update this database with for hu3s193 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 hu3s193 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.