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SKB410

Clinical trials are investigating SKB410 in people with advanced solid tumors, high-risk bladder cancer, and urothelial cancer. These studies are mainly looking at safety, tolerability, and early signs of benefit in Phase 1 settings. The target groups include adults with difficult-to-treat cancers.

Table of Contents

Trial overview

SKB410 is being studied in three interventional trials, which means the researchers give a study treatment and then measure the results.[1][2][3]

All three studies are in Phase 1, an early stage of research that mainly checks safety and tolerability.[1][2][3]

The trials are authorised and focus on adults with different cancer types, including advanced solid tumors, high-risk bladder cancer, and urothelial carcinoma.[1][2][3]

Study in advanced solid tumors

The first study is titled MK-3120-002 and includes people with advanced or metastatic solid tumor disease.[1]

This trial has an enrollment of 281 participants and is designed to evaluate the safety and tolerability of SKB410 used as monotherapy, which means it is given alone.[1]

The main outcomes are the number of participants who experience an adverse event and the number who stop study treatment because of an adverse event.[1]

Study in high-risk bladder cancer

The second study is titled MK-3120-003 and is for people with high-risk non-muscle invasive bladder cancer, also called NMIBC, with carcinoma in situ and possibly papillary tumors.[2]

This trial includes 46 participants and studies SKB410 given by intravesical use, which means it is placed directly into the bladder.[2]

The study aims to evaluate the safety and tolerability of I-VESIC SKB410 monotherapy.[2]

Its main endpoints include dose-limiting toxicity, adverse events, and treatment stop rates because of adverse events.[2]

Study in urothelial cancer

The third study is titled MK-3475-04D and is for people with urothelial carcinoma.[3]

This trial includes 54 participants and studies SKB410 given by intravenous use, which means it is given into a vein, together with enfortumab vedotin and pembrolizumab.[3]

The study looks at safety and tolerability of the combination and also measures Objective Response Rate (ORR) by investigator assessment using RECIST 1.1.[3]

ORR is an early measure of how many people have a tumor response, such as shrinkage or disappearance of cancer on scans.[3]

Main endpoints and what they mean

Across these studies, the most common endpoints are safety-related, especially adverse events and treatment discontinuation because of side effects.[1][2][3]

One study also measures dose-limiting toxicity, which helps show whether a treatment side effect is severe enough to limit use.[2]

The urothelial cancer study adds a response endpoint, ORR, so researchers can see whether the cancer shows an early treatment response.[3]

What patients should know

These studies are not all for the same cancer, so a person’s possible participation depends on the cancer type and the study design.[1][2][3]

The studies are early-phase trials, so the main goal is to learn how SKB410 behaves in people with cancer, especially whether it can be given safely.[1][2][3]

Because one trial uses SKB410 alone, another uses it in the bladder, and another uses it with other cancer treatments, the research program is testing SKB410 in more than one clinical setting.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2024-516817-19-00 Phase 1 Advanced/metastatic solid tumor disease Authorised 281
2025-520467-40-00 Phase 1 High-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors Authorised 46
2025-522253-19-00 Phase 1 Urothelial carcinoma Authorised 54

FAQ

  • What is being studied in SKB410 trials? The trials are studying SKB410 in different cancer settings, including advanced solid tumors, bladder cancer, and urothelial cancer. The main focus is safety and tolerability, with one study also looking at early tumor response.
  • Who can take part in these trials? Each trial has a different target group. People with advanced or metastatic solid tumors, high-risk non-muscle invasive bladder cancer with carcinoma in situ, or urothelial cancer may be eligible, depending on the study.
  • What phase are the SKB410 trials in? All listed trials are Phase 1 studies. Phase 1 usually means the treatment is being tested early in development, mainly to learn how safe and tolerable it is.
  • What safety results are measured? The studies measure adverse events, dose-limiting toxicities, and treatment stop rates because of side effects. These results help show whether the study treatment can be given safely.
  • Do any trials look at whether SKB410 helps the cancer shrink? Yes, one urothelial cancer study measures Objective Response Rate, which means how many people have a measurable tumor response. This is an early sign of whether the treatment may help.

Ongoing Clinical Trials on SKB410

  • Phase 1/2 Evaluation of Zilovertamab Vedotin in PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma

    Recruiting

    2 1 1 1
    Investigated drugs:
    Denmark Italy The Netherlands Spain

  • A study of SKB410, enfortumab vedotin, and pembrolizumab combination for patients with locally advanced or metastatic urothelial cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France The Netherlands Spain

  • Study of MK-3120 for patients with high-risk non-muscle invasive bladder cancer who have not received or have received BCG treatment

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium France Greece Italy The Netherlands +2

  • Study on the Safety and Effects of MK-3120 for Patients with Advanced Solid Tumors

    Recruiting

    1 1 1
    Investigated drugs:
    France The Netherlands Poland Spain

Glossary

  • Advanced solid tumor: A cancer that has grown large, spread, or cannot be removed easily with surgery.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • High-risk non-muscle invasive bladder cancer: A bladder cancer that has not grown into the bladder muscle, but has a higher chance of coming back or getting worse.
  • Carcinoma in situ (CIS): A very early cancer that is still in the top layer of tissue and has not spread deeper.
  • Papillary tumors: Growths that look like small finger-like lumps inside the bladder.
  • Urothelial carcinoma: A cancer that starts in the lining of the urinary tract, including the bladder.
  • Interventional study: A trial where participants receive a study treatment so researchers can measure its effects.
  • Phase 1: An early trial phase that mainly checks safety and tolerability.
  • Safety: How often harmful or unwanted effects happen during a study.
  • Tolerability: How well people can take the study treatment without major problems.
  • Adverse event (AE): Any unwanted medical problem that happens during a trial, whether or not it is caused by the study treatment.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much treatment can be given.
  • Objective Response Rate (ORR): The percentage of people whose cancer gets smaller or disappears on scans or exams.
  • RECIST 1.1: A standard way doctors use to measure whether tumors shrink, stay the same, or grow.

References

  1. https://clinicaltrials.gov/study/2024-516817-19-00
  2. https://clinicaltrials.gov/study/2025-520467-40-00
  3. https://clinicaltrials.gov/study/2025-522253-19-00