NCT07600476RecruitingPhase 1
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 3 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Kupando GmbH
- Diseases
- Melanoma
- NCT number
- NCT07600476
- EU CT number
- 2025-522402-21-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 3 Jul 2026 to the primary completion date, 31 Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known additional malignancy that is progressing or requires active treatment
- High grade ocular disease such as uncontrolled glaucoma
Other
- Diagnosis of immunodeficiency
- Any kind of leukemia
- Known active central nervous system metastases and/or carcinomatous meningitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Josef Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Fachklinik Hornheide e.V. Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.