CLINICAL TRIAL

KN046 for Carcinoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a new drug can help people with advanced thymic cancer.

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About the trial for Carcinoma

Eligible Conditions
Carcinoma · Thymoma · Thymic Carcinoma

Treatment Groups

This trial involves 2 different treatments. KN046 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 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
KN046
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. 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:
ECOG performance status of 0 or 1.
ANC≥1.5 x 109/L; Hemoglobin≥9 g/dL; Platelets≥100 x 109/L
Signed informed consent form.
Male or female, 18 years of age or older; willing and able to complete all required procedures of study.
Pathologically confirmed diagnosis of thymic carcinoma; a tumor sample is required for confirmation of pathological diagnosis and further studies on the tumor tissue.
Inoperable or metastatic disease.
Progressive disease documented in the last 6 months.
Has failed platinum-based chemotherapy, with progression either during or after treatment.
Had failed at least one regimen of systemic therapy containing immune checkpoint blockade therapy targeting PD-1, PD-L1, or CTLA-4 for locally advanced unresectable or metastatic disease. Subjects should have documented progressive disease while or after an immune checkpoint therapy. If subjects discontinued therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of immune checkpoint therapy.
Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
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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: Through study completion (an average of 2 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion (an average of 2 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion (an average of 2 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 KN046 will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of From baseline to death due to underlying cancer (on average 30 months).

Overall Survival (OS) for KN046 in subjects with thymic carcinoma, determined by subject disease response rate defined by the RECIST 1.1 criteria.
FROM BASELINE TO DEATH DUE TO UNDERLYING CANCER (ON AVERAGE 30 MONTHS)
In previous studies, OS has not been reached. However OS rates for 6 and 9 months were 74.3% and 65.2%, respectively.
FROM BASELINE TO DEATH DUE TO UNDERLYING CANCER (ON AVERAGE 30 MONTHS)
Duration of response for KN046 in subjects with thymic carcinoma, determined by subject disease response rate defined by the RECIST 1.1 criteria.
FROM FIRST DOCUMENTED RESPONSE (PR OR CR) TO THE DATE OF FIRST DOCUMENTED DISEASE PROGRESSION OR DEATH DUE TO UNDERLYING CANCER (AN AVERAGE OF 2 YEARS)
FROM FIRST DOCUMENTED RESPONSE (PR OR CR) TO THE DATE OF FIRST DOCUMENTED DISEASE PROGRESSION OR DEATH DUE TO UNDERLYING CANCER (AN AVERAGE OF 2 YEARS)
Progression Free Survival (PFS) for KN046 in subjects with thymic carcinoma, determined by subject disease response rate defined by the RECIST 1.1 criteria.
FROM START OF TREATMENT TO TIME OF PROGRESSION (AN AVERAGE OF 2 YEARS)
FROM START OF TREATMENT TO TIME OF PROGRESSION (AN AVERAGE OF 2 YEARS)
Tolerability of KN046 in subjects with thymic carcinoma, measured by the severity of adverse events that occur in subjects while receiving study treatment, assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)
Safety of KN046 in subjects with thymic carcinoma, measured by the number of adverse events that occur in subjects while receiving study treatment.
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)
Anti-tumor activity of KN046 in subjects with thymic carcinoma, determined by subject disease response rate defined by the RECIST 1.1 criteria.
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)
Disease response rate
THROUGH STUDY COMPLETION (AN AVERAGE OF 2 YEARS)

Patient Q & A Section

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

Can carcinoma be cured?

The majority of patients will experience disease progression within 2 years of diagnosis. Prospective studies should evaluate the impact of specific treatments on the long-term prognosis.

Anonymous Patient Answer

How quickly does carcinoma spread?

The primary tumor of carcinoma is not always the first site of metastatic dissemination. In addition, even when it is the first site of metastatic dissemination, the lung may be the only organ that presents metastases.

Anonymous Patient Answer

What is the survival rate for carcinoma?

For lung and brain, the 5 year survival rate for carcinomas was 27%. The 5 year survival rate for bone was 39%, and that for colon was 35%. For breast carcinoma, the 5 year survival rate was 23%. These data show that the survival rate for carcinomas varies according to the primary site of origin.

Anonymous Patient Answer

What is the primary cause of carcinoma?

Recent findings suggest that there is a strong association between alcohol consumption and the development of adenocarcinoma with high-grade dysplasia, but no association between alcohol consumption and esophageal squamous cell carcinoma or adenosquamous carcinoma. Recent findings support the hypothesis that intestinal metaplasia precedes adenocarcinoma.

Anonymous Patient Answer

What is the average age someone gets carcinoma?

It has been estimated that carcinoma occurs at a rate of one per 100,000 people each year. The average age of diagnosis for carcinoma is 70.6 years.

Anonymous Patient Answer

Does carcinoma run in families?

Results from a recent clinical trial suggests that there is no evidence for an excess of cancer in families with more than one first degree relative with the disease. Atypical colorectal adenomas were significantly associated with family history of colon cancer. However we found no significant association between familial [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s and prostate specific antigen serum levels.

Anonymous Patient Answer

What causes carcinoma?

There are many different factors that contribute to the development of carcinoma, including genetic predisposition, environmental exposures, and other unknown causes. The most common cancers are lung, breast, colon, prostate, and stomach. Lung cancer is the second leading cause of death in the United States, accounting for about 15% of deaths. Breast cancer is the third leading cause of death in the United States, with more than 5,000 deaths per year. In addition to being the third leading cause of death, breast cancer accounts for 20% of all cases of cancer diagnosed in the United States. Colon cancer is the fourth leading cause of death in the United States, with about 6,500 deaths per year.

Anonymous Patient Answer

What does kn046 usually treat?

Most patients who received the KN046 regimen did so for pain control. The lack of evidence regarding its effectiveness for any other indications suggests that this drug may be underused.

Anonymous Patient Answer

How many people get carcinoma a year in the United States?

The current data suggest that the incidence of carcinoma in the United States for men is increasing, but this rate may be changing because of earlier detection of early-stage cancers. For women, there appears to be no change in rates of carcinoma over time.

Anonymous Patient Answer

What are common treatments for carcinoma?

Patients with carcinoma will receive different treatments depending on their stage of the disease, overall health, and personal preferences. Although supportive care is often offered with metastatic cancer, there is still much research needed to develop effective anti-tumor therapies.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma?

There have been numerous advances in understanding the biology of cancers and it is probable that many will continue to make significant contributions over the next few decades. New treatments have now become more available and some show promise. One example is targeting the vascular endothelial growth factor (VEGF), which has been shown to be an important mediator of tumour invasion and angiogenesis. VEGF inhibitors such as bevacizumab (Avastin; Bayer AG) have been used successfully in combination with other agents in the treatment of metastatic colorectal cancer.

Anonymous Patient Answer
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