A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
About this study
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.
- Condition
- Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Basal Cell Carcinoma of Skin
- Tested
- KUP-101A
- Sponsor
- Kupando GmbH
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 18 years
- Study condition: Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Basal Cell Carcinoma of Skin
- 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 11
- 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
3 sites, 3 recruiting
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie
Munich, Bavaria, Germany
Fachklinik Hornheide
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Contact
-
Clinical Operations
+49 30 52 00 58 60 20 clinicaltrials@kupando.com
Potential match only. Final eligibility is determined by the study team.