Actively Recruiting
Phase 1 Study to Find the Safe Dose and Effects of KUP-101A Given by IV in Adults With Advanced Skin and Other Selected Cancers
Led by Kupando GmbH · Updated on 2026-08-12
21
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KUP-101A in patients with selected advanced solid tumors such as cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma of skin, and basal cell carcinoma of skin. The study aims to find the maximum tolerated dose and the recommended Phase 2 dose of KUP-101A. It also seeks to assess the drugs safety, tolerability, pharmacokinetics, and pharmacodynamics while gathering initial data on its efficacy in these patients. Participants receive intravenous infusions of KUP-101A at various dose levels, progressing sequentially to determine the best dose for further study. There are multiple experimental dose levels ranging from dose level 1 to dose level 7. The study follows a non-randomized design without blinding. Treatment continues while monitoring for dose-limiting toxicities and adverse events. During the trial, participants undergo evaluations for adverse events, laboratory tests including hematology and clinical chemistry, urinalysis, and vital signs, as well as 12-lead ECG monitoring. Pharmacokinetic parameters such as drug concentration and elimination half-life are measured up to three weeks, with safety assessments extending to three months after the last dose. The total participation timeline includes enrollment, treatment, and follow-up periods for safety and pharmacodynamic assessments.
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 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
- 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 recent myocardial infarction within 6 months before screening
- High grade ocular disease such as uncontrolled glaucoma
Research Team
C
Clinical Operations
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here