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New treatment option for Solid Tumor
Official title KN035 for dMMR/MSI-H Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03667170
What this study is testing
What is KN035?
KN035 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy. For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
- Confirmed MMR deficient or MSI-H status.
- At least one measureable lesion.
- Eastern Cooperative Oncology Group performance status of 0 or 1 .
- Life expectancy of greater than 12 weeks.
You likely can't join if
- Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the...
- Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
- Has received prior therapy with an immune check point agonist/inhibitor.
- Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
- Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
See the full eligibility criteria
- Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
- Confirmed MMR deficient or MSI-H status.
- At least one measureable lesion.
- Eastern Cooperative Oncology Group performance status of 0 or 1 .
- Life expectancy of greater than 12 weeks.
- Adequate hematologic and organ function.
- Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific...
- Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
- Has received prior therapy with an immune check point agonist/inhibitor.
- Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
- Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment.
- Patients who have known history of infection with HIV.
- Patients with evidence of interstitial lung disease.
- Patients who have known history of any major cardiac abnormalities.
- Patient who is not willing to apply highly effective contraception during the study.
- Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.