Actively Recruiting
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Led by Kupando GmbH · Updated on 2026-05-20
21
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KUP-101A, a drug given by intravenous infusion, in patients with certain advanced solid tumors including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma of the skin, and basal cell carcinoma of the skin. This Phase 1 trial aims to find the highest dose of KUP-101A that patients can tolerate and to assess its safety and how it behaves in the body. Researchers will also gather initial data on how well KUP-101A works for these patients. Participants will receive KUP-101A at increasing dose levels, starting from Dose level 1 up to Dose level 7, to determine the recommended dose for further studies. The drug is given through infusion into a vein. The study is not randomized or blinded, meaning all participants receive the investigational treatment. The trial will monitor patients from enrollment and during treatment to observe any side effects, dose-limiting toxicities, and laboratory test results. During the study, patients will be closely monitored for adverse events, changes in laboratory values, vital signs, and heart function using electrocardiograms (ECG). Researchers will also assess pharmacokinetic measures such as drug concentration in the blood over time and the drug's elimination half-life. Cytokine levels will be measured to understand immune responses. Safety follow-up will continue for three months after the last dose. Participation duration and visit schedules will depend on the dosing and monitoring requirements.
CONDITIONS
Brief Title
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Previous systemic treatment with TLR agonists, except 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 requiring systemic immunosuppressive treatment in the past 2 years
- Active autoimmune disease caused by prior anticancer treatment unless controlled by replacement therapy only
- Any kind of leukemia
- Previous organ transplant (other than corneal) or hematopoietic stem cell transplantation
- Known active central nervous system metastases or carcinomatous meningitis
- Cerebral vascular event within 6 months before screening
- Unstable cardiopulmonary status including uncontrolled congestive heart failure NYHA Grade III or IV, unstable angina, or myocardial infarction within 6 months before screening
- High grade ocular disease such as uncontrolled glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants receive intravenous infusions of KUP-101A at increasing dose levels to evaluate safety and drug effects.
Multiple visits for intravenous infusions and assessments during treatment
Duration - Up to 3 months after last dose
Participants are monitored for safety and laboratory abnormalities for up to three months after the last dose administration.
Periodic visits for safety and laboratory assessments
Trial Site Locations
Total: 2 locations
1
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
2
Fachklinik Hornheide
Münster, North Rhine-Westphalia, Germany, 48157
Actively Recruiting
Research Team
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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