Clinical trial · Interventional
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
NCT07600476CI-TRIAL-00121583recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Squamous Cell Carcinoma (CSCC) | Skin Squamous Cell Carcinoma | ALIAS | 0.85 |
| Merkel Cell Carcinoma of Skin | — | UNRESOLVED | — |
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KUP-101A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dose level 1
- interventionNames
- Drug: KUP-101A
- type
- EXPERIMENTAL
- label
- Dose level 2
- interventionNames
- Drug: KUP-101A
- type
- EXPERIMENTAL
- label
- Dose level 3
- interventionNames
- Drug: KUP-101A
- type
- EXPERIMENTAL
- label
- Dose level 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.