First-in-human test of KUP-101A in selected advanced skin cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1 trial aims to determine the maximum tolerated dose and recommended phase 2 dose of KUP-101A, while assessing safety, tolerability, and pharmacokinetics/pharmacodynamics in patients with advanced solid tumors including various skin cancers. The study will also collect preliminary signals of efficacy in this population. Eligible participants have histologically confirmed advanced cancer with no standard treatment options, good performance status, and adequate organ function. Key exclusion criteria include prior systemic TLR agonist therapy (except vaccine adjuvants), active autoimmune disease, active CNS metastases, and recent organ transplantation. The trial is conducted at several German academic centers under Kupando GmbH as lead sponsor.

Why it matters

Who can join: the full rules

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's running

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

Study contacts

• Study coordinator: Clinical Operations
• Email: clinicaltrials@kupando.com
• Phone: +49 30 52 00 58 60 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.