A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
Recruiting · NCT07600476 · Interventional (participants receive a specific treatment) · Lead sponsor: Kupando GmbH
View the official record on ClinicalTrials.gov →Interventions studied
KUP-101A
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
3 locations listed.
- Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie - Munich, Bavaria, Germany
- Universitätsklinikum Würzburg - Würzburg, Bavaria, Germany
- Fachklinik Hornheide - Münster, North Rhine-Westphalia, Germany