BridgeMD
Tests treatment safety and results for Cutaneous Melanoma
Official title A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07600476
What this study is testing
What is KUP-101A?
KUP-101A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous melanoma.
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
- The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.
- Phase 1: an early, usually small safety study
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 cancer with evidence of advanced disease for which no other standard treatment is available
- ECOG Performance status of 0 to 2
- Adequate hematological, renal, and hepatic organ function
You likely can't join if
- Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.
- Known additional malignancy that is progressing or requires active treatment
- Diagnosis of immunodeficiency
- Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years
- Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.
- Any kind of leukemia
See the full eligibility criteria
- Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available
- ECOG Performance status of 0 to 2
- Adequate hematological, renal, and hepatic organ function
- Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.
- Known additional malignancy that is progressing or requires active treatment
- Diagnosis of immunodeficiency
- Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years
- Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.
- Any kind of leukemia
- Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation
- Known active central nervous system metastases and/or carcinomatous meningitis
- Cerebral vascular event within 6 months before Screening
- Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening
- High grade ocular disease such as uncontrolled glaucoma
The study team makes the final eligibility decision.
Where it's taking place
- Würzburg, Bavaria, Germany
- Münster, North Rhine-Westphalia, Germany
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 Würzburg, Bavaria, Germany; Münster, North Rhine-Westphalia, Germany. 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.