RecruitingPhase 1

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

Germany21 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs

Timeframe: From enrollment until three months after last dose administration

Proportion of patients with dose-limiting toxicities (DLTs)

Timeframe: From start of treatment until one week after last dose administration.

Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

Timeframe: From enrollment until three months after last dose administration

Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs

Timeframe: From enrollment until three months after last dose administration

Trial details

NCT IDNCT07600476

SponsorKupando GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Clinical Operations

+49 30 52 00 58 60 20 clinicaltrials@kupando.com

View on ClinicalTrials.gov More Cutaneous Melanoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs

Timeframe: From enrollment until three months after last dose administration

Proportion of patients with dose-limiting toxicities (DLTs)

Timeframe: From start of treatment until one week after last dose administration.

Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

Timeframe: From enrollment until three months after last dose administration

Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs

Timeframe: From enrollment until three months after last dose administration