Cutaneous MelanomaMucosal MelanomaCutaneous Squamous Cell Carcinoma (CSCC)Merkel Cell Carcinoma of SkinBasal Cell Carcinoma of Skin
Investigational drug(s) / intervention(s)
KUP-101A
KUP-101A: Intravenous infusion of KUP-101A
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
Trial sites (3)
Facility
City
Region
Status
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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