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

May 13, 2026 updated by: Kupando GmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitatsklinikum Wurzburg
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48157
        • Recruiting
        • Fachklinik Hornheide

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 2
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 3
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 4
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 5
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 6
Drug: KUP-101A
Intravenous infusion of KUP-101A
Experimental: Dose level 7
Drug: KUP-101A
Intravenous infusion of KUP-101A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
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
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
From enrollment until three months after last dose administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity
Time Frame: up to 3 weeks
up to 3 weeks
Maximum Observed Concentration
Time Frame: up to 3 weeks
up to 3 weeks
Time of the maximum observed concentration
Time Frame: up to 3 weeks
up to 3 weeks
Apparent terminal elimination half-life
Time Frame: up to 3 weeks
up to 3 weeks
Change from baseline in cytokine levels
Time Frame: From enrollment until three months after last dose administration
From enrollment until three months after last dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kupando GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUP-CT01
  • 2025-522402-21-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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