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Recruiting NCT07600476

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

Phase I Interventional Cutaneous Melanoma Mucosal Melanoma Cutaneous Squamous Cell Carcinoma (CSCC) Merkel Cell Carcinoma of Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KUP-101A.
Who it may be relevant to
Registry conditions: Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug KUP-101A
    Intravenous infusion of KUP-101A

Primary outcome measures

  • Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs [Time frame: From enrollment until three months after last dose administration]
  • Proportion of patients with dose-limiting toxicities (DLTs) [Time frame: From start of treatment until one week after last dose administration.]
  • Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [Time frame: From enrollment until three months after last dose administration]
  • Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs [Time frame: From enrollment until three months after last dose administration]
Secondary outcome measures (5)
  • Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity [Time frame: up to 3 weeks]
  • Maximum Observed Concentration [Time frame: up to 3 weeks]
  • Time of the maximum observed concentration [Time frame: up to 3 weeks]
  • Apparent terminal elimination half-life [Time frame: up to 3 weeks]
  • Change from baseline in cytokine levels [Time frame: From enrollment until three months after last dose administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 2 centers
  • Universitätsklinikum Würzburg — Würzburg
  • Fachklinik Hornheide — Münster

Identifiers

NCT: NCT07600476 · KUP-CT01 · 2025-522402-21-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗