CLINICAL TRIAL

SGN-B7H4V for HER2 Negative Breast Neoplasms

Recruiting · 18+ · All Sexes · Denver, CO

A Study of SGN-B7H4V in Advanced Solid Tumors

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About the trial for HER2 Negative Breast Neoplasms

Eligible Conditions
HER2 Negative Breast Neoplasms · Carcinoma · Neoplasms · Breast Neoplasms · Endometrial Neoplasms · Triple Negative Breast Neoplasms · Hormone Receptor Positive Breast Neoplasms · Cholangiocarcinoma · Peritoneal Neoplasms · Carcinoma of Gallbladder · HER2 Positive Breast Neoplasms · Carcinoma, Non-Small-Cell Lung · Fallopian Tube Neoplasms · Ovarian Neoplasms

Treatment Groups

This trial involves 2 different treatments. SGN-B7H4V is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SGN-B7H4V
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for HER2 Negative Breast Neoplasms or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
HER2-negative, HR positive breast cancer
Triple-negative breast cancer (TNBC)
Endometrial carcinoma
Squamous non-small cell lung cancer (Sq-NSCLC)
Cholangiocarcinoma or gallbladder carcinoma
Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
Part C: Subjects must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease per RECIST version 1.1 at baseline
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to approximately 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to approximately 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SGN-B7H4V will improve 3 primary outcomes and 11 secondary outcomes in patients with HER2 Negative Breast Neoplasms. Measurement will happen over the course of Up to 28 days.

Number of participants with dose limiting toxicities (DLTs)
UP TO 28 DAYS
PK parameter - Time to maximum concentration (Tmax)
THROUGH 30-37 DAYS AFTER LAST STUDY TREATMENT, UP TO APPROXIMATELY 3 YEARS
To be summarized using descriptive statistics.
Incidence of antidrug antibodies (ADAs)
THROUGH 30-37 DAYS AFTER LAST STUDY TREATMENT, UP TO APPROXIMATELY 3 YEARS
To be summarized using descriptive statistics.
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
THROUGH 30-37 DAYS AFTER LAST STUDY TREATMENT; UP TO APPROXIMATELY 3 YEARS
To be summarized using descriptive statistics.
PK parameter - Apparent terminal half-life (t1/2)
THROUGH 30-37 DAYS AFTER LAST STUDY TREATMENT, UP TO APPROXIMATELY 3 YEARS
To be summarized using descriptive statistics.
PK parameter - Maximum concentration (Cmax)
THROUGH 30-37 DAYS AFTER LAST STUDY TREATMENT, UP TO APPROXIMATELY 3 YEARS
To be summarized using descriptive statistics.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of her2 negative breast neoplasms?

Signs of her2 negative breast neoplasms are present at presentation and can include a palpable lump, nipple discharge, lumps on other body sites and enlargement of the axillary lymph nodes.\n

Anonymous Patient Answer

What causes her2 negative breast neoplasms?

Her2/neu loss-of-action and overexpression are not rare events leading to breast cancer. HER2/neu can be overexpressed in tumors of women with no known genetic susceptibility to Her2/neu, or it can be shed from the tumor of women with a her2 mutation but no somatic EGFR gene amplification. Tumor proteins, such as p63 or MUC-1, inactivation of the Her2/neu receptor, may contribute to tumorigenesis. Data from a recent study underscore the need for improved diagnostic approaches in diagnosing and treating patients with breast cancer.

Anonymous Patient Answer

What are common treatments for her2 negative breast neoplasms?

In the era of hormonal blockage therapy and targeted therapy, patients with HER2 negative breast cancers should be discussed with a multidisciplinary expert, and a discussion should include treatment options.

Anonymous Patient Answer

How many people get her2 negative breast neoplasms a year in the United States?

Around 32,000 people in the US get a her2 negative breast neoplasm annually. Around 40% of those with HER2 amplification require trastuzumab for disease treatment.

Anonymous Patient Answer

Can her2 negative breast neoplasms be cured?

Data from a recent study are not yet convincing enough to prove the existence of a cure for her2-positive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). However, our data shows a possible improvement with time. Thus, new, larger clinical trials are justified to determine if there is at the moment a cure for patients with her2-positive breast-cancer. Future trials are also warranted in patients negative for ER.

Anonymous Patient Answer

What is her2 negative breast neoplasms?

HER2 expression is often present in ductal carcinomas in situ and it is common in invasive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s. HER2 expression is also present in a subset of breast tumors that share a profile with some triple negative breast cancers.

Anonymous Patient Answer

What is the survival rate for her2 negative breast neoplasms?

Her2 overexpression is associated with aggressive disease behavior and poor outcome in breast carcinomas. This overexpression of the ER-alpha and/or c-HER2 genes can be evaluated by utilizing the FDA-approved Herceptin(trastuzumab). It appears that the clinical significance of the Herceptin-positive Her2-negative breast tumors has been underestimated. This is evidenced through the poorer outcome of the patients treated with Herceptin versus patients treated with Herceptin-containing regimens.

Anonymous Patient Answer

Has sgn-b7h4v proven to be more effective than a placebo?

SGN-B7h4v as an anti HER2 monoclonal antibody demonstrated a significant improvement in tumor-free and overall survival. Therefore, SGN-B7h4v is highly recommended for the treatment of HER2-negative recurrent breast cancer regardless of their expression of HER2.

Anonymous Patient Answer

What is the primary cause of her2 negative breast neoplasms?

Her2 negative breast cancer development may be multifactorial. The most common causes of her2 negative breast cancer appear to be the local environment, tumor microfiltrating lymphocytes, HER2 gene and the presence of a family history of breast cancer.

Anonymous Patient Answer

Is sgn-b7h4v safe for people?

Sgn-b7h4v, administrated intravenously at a dose of 4.5 mg, caused no detectable side-effects in the first 30 days of the treatment, and no clinical symptoms of systemic side-effect were observed in both patients and controls. Sgn-b7h4v is a promising new medication for the treatment of patients with advanced breast cancer.

Anonymous Patient Answer

What are the latest developments in sgn-b7h4v for therapeutic use?

SGN-b7h4v is a new antibody conjugated to the VH3 domain derived from the SGN VH3 domain. It is an antibody that has shown potent growth and proliferation inhibition activity against tumor cell lines in both in vitro and in vivo studies. Further studies are needed to determine the applicability of sgn-b7h4v in breast cancer patients for the therapeutic utility.

Anonymous Patient Answer

What are the common side effects of sgn-b7h4v?

In a recent study, findings identified the common side effects of sgn-b7h4v, which include fatigue, weight loss, nausea, cough, and diarrhea. Based on these side effects, clinicians should monitor the side effects during the treatment of SGN-P1 patients.

Anonymous Patient Answer
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