Basal Cell Carcinoma of Skin, Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Mucosal Melanoma
Conditions
Keywords
TLR4 agonist, TLR7 agonist, TLR4/7 agonist, skin cancer, innate immunity, immunotherapy
Brief summary
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.
Interventions
DRUGKUP-101A
Intravenous infusion of KUP-101A
Sponsors
Kupando GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs | From enrollment until three months after last dose administration |
| Proportion of patients with dose-limiting toxicities (DLTs) | From start of treatment until one week after last dose administration. |
| Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results | From enrollment until three months after last dose administration |
| Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs | From enrollment until three months after last dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity | up to 3 weeks |
| Maximum Observed Concentration | up to 3 weeks |
| Time of the maximum observed concentration | up to 3 weeks |
| Apparent terminal elimination half-life | up to 3 weeks |
| Change from baseline in cytokine levels | From enrollment until three months after last dose administration |
Countries
Germany
Contacts
CONTACTClinical Operations
Outcome results
None listed