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
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07600476
- Acronym / sponsor ID
- KUP-CT01
- Conditions
- Cutaneous Melanoma, Mucosal Melanoma, Cutaneous Squamous Cell Carcinoma (CSCC), Merkel Cell Carcinoma of Skin, Basal Cell Carcinoma of Skin
- Keywords
- TLR4 agonist, TLR7 agonist, TLR4/7 agonist, skin cancer, innate immunity, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Kupando GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: KUP-101A |
| Dose level 2 | Experimental | Drug: KUP-101A |
| Dose level 3 | Experimental | Drug: KUP-101A |
| Dose level 4 | Experimental | Drug: KUP-101A |
| Dose level 5 | Experimental | Drug: KUP-101A |
| Dose level 6 | Experimental | Drug: KUP-101A |
| Dose level 7 | Experimental | Drug: KUP-101A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KUP-101AIntravenous infusion of KUP-101A | Drug | Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5, Dose level 6, Dose level 7 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KUP-101A in people with Cutaneous Melanoma and Mucosal Melanoma, run by Kupando GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (+49 30 52 00 58 60 20, clinicaltrials@kupando.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.