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Clinical Trials in Germany / NCT07600476
Recruiting Phase 1

A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors

NCT07600476 · tracked via the Priya Life Science Germany tracker
Sponsor
Kupando GmbH
Phase
Phase 1
Started
2026-07-03
Last updated
2026-08-12

Condition(s) studied

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)

Trial sites (3)

FacilityCityRegionStatus
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie Munich Bavaria Recruiting
Universitätsklinikum Würzburg Würzburg Bavaria Recruiting
Fachklinik Hornheide Münster North Rhine-Westphalia Recruiting

Other trials for the same condition

Official registry record

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.

View NCT07600476 on ClinicalTrials.gov ↗ ← All trials in Germany