Cutaneous MelanomaPhase 1NCT07600476
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
A Phase 1 study testing KUP-101A in people with Cutaneous Melanoma and Mucosal Melanoma, run by Kupando GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC)
- What is being tested?
- KUP-101A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesGermany
- Study dates
- 3 Jul 2026to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie
Munich, Bavaria, 80337
- Recruiting
Fachklinik Hornheide
Münster, North Rhine-Westphalia, 48157
- Recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
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.
- Conditions
- Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Basal Cell Carcinoma of Skin
- Being tested
- KUP-101A
- Keywords
- TLR4 agonist, TLR7 agonist, TLR4/7 agonist, skin cancer, innate immunity, immunotherapy
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUP-101ADrug
Intravenous infusion of KUP-101A
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 2 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 3 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 4 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 5 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 6 | Experimental | Not described Receives: Drug: KUP-101A |
| Dose level 7 | Experimental | Not described Receives: Drug: KUP-101A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs
Measured: From enrollment until three months after last dose administration
Proportion of patients with dose-limiting toxicities (DLTs)
Measured: From start of treatment until one week after last dose administration.
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Measured: From enrollment until three months after last dose administration
Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs
Measured: From enrollment until three months after last dose administration
Secondary outcomes (5)
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity
Measured: up to 3 weeks
Maximum Observed Concentration
Measured: up to 3 weeks
Time of the maximum observed concentration
Measured: up to 3 weeks
Apparent terminal elimination half-life
Measured: up to 3 weeks
Change from baseline in cytokine levels
Measured: From enrollment until three months after last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start3 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kupando GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600476
- Sponsor's protocol ID
- KUP-CT01
- Other IDs
- 2025-522402-21-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No