KN026 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Greenville Health System Center Institute, Greenville, SC
Breast Cancer+2 More
KN026 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether KN026 can be safely given to people with HER2 positive advanced breast and gastric cancer.

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Eligible Conditions

  • Breast Cancer
  • Gastric/Gastroesophageal Junction Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

This trial is evaluating whether KN026 will improve 1 primary outcome and 6 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of From screening to up to 28 days.

Day 196
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
Day 28
The proportion of patients experiencing dose limiting toxicities
Year 2
Frequency and titer of anti-KN026 antibody
Progression free survival according to RECIST 1.1 criteria
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria
Day 84
Maximum observed serum concentration (Cmax) of KN026
Time of Maximum observed serum concentration (Tmax) of KN026

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

1 Treatment Group

KN026
1 of 1
Experimental Treatment

This trial requires 22 total participants across 1 different treatment group

This trial involves a single treatment. KN026 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.

KN026
Drug
Patient will be intravenously administrated with one dose of KN026. Dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the duration of the study; up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly throughout the duration of the study; up to 2 years for reporting.

Closest Location

Greenville Health System Center Institute - Greenville, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female subject >= 18 years
Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
ECOG score 0 or 1
Life expectancy >3 months
According to the definition of RECIST1.1, the patient has at least one measurable lesion
Adequate organ function prior to start treatment with KN026
Able to understand, voluntarily participate and willing to sign the ICF
Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Patient Q&A Section

How many people get breast cancer a year in the United States?

"Almost 4 to 6% of women are diagnosed with breast cancer in the US in a single calendar year. Older women have the highest risk of being diagnosed a year.  A variety of factors appear to be associated with receipt of care among those diagnosed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Many treatments are used to treat [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), but because no cure exists, each treatment approach is used depending on the type of cancer and staging, type, and stage of the patients." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"The authors suggest: “The current notion that BC is incurable appears to be based on an overestimate of the risk of disease progression. Although progression of BC continues with variable frequency, its overall frequency appears to be stable, particularly when compared with other cancers.” The authors state that “the survival of early metastatic BC may be improved by clinical, pathological, and treatment characterization of the tumor." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The onset of breast cancer appears to have environmental and genetic determinants. Breast cancers may be a product of cumulative and repeated exposure to environmental risk factors, such as tobacco, chemicals, or infectious agents. Genetic variants predisposing to breast cancer have been recently identified, including variants such as breast cancer susceptibility genes BRCA1 or BRCA2, and genes involved in breast cancer progression." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include nipple atrophy, nipple discharge, a lump in the breast, and axillary lymphadenopathy. These symptoms may also be associated with other breast conditions such as mastitis, breast tenderness, and nipple discharge." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a common cancer that forms from the cells of breast tissues. It is the most common solid cancer, accounting for 5 % of all cancer cases in the USA." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"All forms of estrogen are associated with increased breast cancer risk, with the exception of estradiol-only users, and with other forms of synthetic estrogen-like hormones, such as diethylstilbestrol and diethylstilbestrol metabolites." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of kn026?

"The common side effects of kn026 in patients with non-[metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) were: decreased weight, nausea, and fatigue. A few cases of decreased appetite occurred, which were not serious. The side effects of kn026 in patients with metastatic breast cancer were headache and vomiting." - Anonymous Online Contributor

Unverified Answer

Has kn026 proven to be more effective than a placebo?

"Results from a recent clinical trial of this study show that in spite of having high grade tumors and positive nodes, the cancer patient treated by topical imidazole and topical calcineurin inhibitors had an excellent functional recovery, an almost complete regression, and lower mortality than the placebo." - Anonymous Online Contributor

Unverified Answer

Does kn026 improve quality of life for those with breast cancer?

"Patients in the kn026 group benefited from this regimen compared to both placebo and conventional care only, but only with regard to functional and emotional QoL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"New research on the metastatic and hormonal treatment of breast cancer with the advancement to gene therapy and immunotherapy have contributed significantly to the understanding and treatment of this diseases. It is also important to develop treatment guidelines for breast cancer due to the growing number of patients undergoing therapy as well as the growing number of patients opting for surveillance rather that curative treatment. Research in breast cancer have led to the identification and development of therapies and targets for treatment, and for more advanced diagnosis and the development of prognostic tools. Recently, research in the area of epigenetics has also emerged, and the first FDA approved drug for the treatment of breast cancer was an epigenetic drug, Tamoxifen, which was FDA approved to treat and prevent breast cancer." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast cancer?

"Clinicians will most often discuss and offer clinical trial options with their patients at diagnosis and during follow-up visits. Physicians should ask and assess for patient preference and understand patient perceptions about clinical trial options because patients may not be willing to participate in a clinical trial if they want standard therapies to be tried." - Anonymous Online Contributor

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