NCT07600476

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
31mo left

Started Apr 2026

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

April 30, 2026

Last Update Submit

May 13, 2026

Conditions

Cutaneous MelanomaMucosal MelanomaCutaneous Squamous Cell Carcinoma (CSCC)Merkel Cell Carcinoma of SkinBasal Cell Carcinoma of Skin

Keywords

TLR4 agonistTLR7 agonistTLR4/7 agonistskin cancerinnate immunityimmunotherapy

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • 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

    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

Study Arms (7)

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

Interventions

KUP-101ADRUG

Intravenous infusion of KUP-101A

Dose level 1Dose level 2Dose level 3Dose level 4Dose level 5Dose level 6Dose level 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Fachklinik Hornheide

Münster, North Rhine-Westphalia, 48157, Germany

RECRUITING

MeSH Terms

Conditions

MelanomaCarcinoma, Basal CellSkin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal Cell

Central Study Contacts

Clinical Operations

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 20, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)