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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522402-21-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental |
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| Dose level 2 | Experimental |
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| Dose level 3 | Experimental |
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| Dose level 4 | Experimental |
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| Dose level 5 | Experimental |
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| Dose level 6 | Experimental |
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| Dose level 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KUP-101A | Drug | Intravenous infusion of KUP-101A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs | From enrollment until three months after last dose administration | |
| Proportion of patients with dose-limiting toxicities (DLTs) | From start of treatment until one week after last dose administration. | |
| Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results | From enrollment until three months after last dose administration | |
| Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs | From enrollment until three months after last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity | up to 3 weeks | |
| Maximum Observed Concentration | up to 3 weeks | |
| Time of the maximum observed concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | +49 30 52 00 58 60 20 | clinicaltrials@kupando.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany | |
| Fachklinik Hornheide |
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| up to 3 weeks |
| Apparent terminal elimination half-life | up to 3 weeks |
| Change from baseline in cytokine levels | From enrollment until three months after last dose administration |
| Recruiting |
| Münster |
| North Rhine-Westphalia |
| 48157 |
| Germany |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002280 | Carcinoma, Basal Cell |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018295 | Neoplasms, Basal Cell |
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