First test of KUP-101A in advanced melanoma and other skin cancers
Tests KUP-101A for safety in adults with advanced skin and mucosal cancers.
Plain-language title generated from the registry record
Registry title: A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Key facts
- Where
- Bochum, Cologne, Marburg, Muenster, Munich, and Wuerzburg, GermanySee the 6 sites
- Phase
- Phase 1
Where in Germany
- St. Josef HospitalBochum, GermanyTaking people
- Universitaetsklinikum Koeln AöRCologne, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Fachklinik Hornheide e.V.Muenster, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kupando GmbH
- Trial code
- NCT07600476EU 2025-522402-21-00
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
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.
Inclusion: 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.
Exclusion: Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants; 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; Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation; 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; Known additional malignancy that is progressing or requires active treatment; High grade ocular disease such as uncontrolled glaucoma; Diagnosis of immunodeficiency; Any kind of leukemia; Known active central nervous system metastases and/or carcinomatous meningitis.