A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Basal Cell Carcinoma of Skin
In brief
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.
Key facts
- Study ID
- NCT07600476
- Run by
- Kupando GmbH
- People needed
- 21
- Starts
- 2026-04-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 may not qualify 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
- 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
Where it is running
- Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany (enrolling)
- Fachklinik Hornheide — Münster, North Rhine-Westphalia, Germany (enrolling)
Full record on ClinicalTrials.gov
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