In short
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.
Key points
- Clinical trials of SKB410 are being done in people with advanced solid tumors, high-risk bladder cancer, and urothelial cancer. All listed studies are Phase 1, so they are early trials that mainly check safety and tolerability. One study also looks at early cancer response using Objective Response Rate. The trial groups are adults with hard-to-treat cancers, and the studies are currently authorised. Together, these trials are testing SKB410 in different cancer settings to learn more about its clinical use.
Trial overview
SKB410 is being studied in three interventional trials, which means the researchers give a study treatment and then measure the results.
All three studies are in Phase 1, an early stage of research that mainly checks safety and tolerability.
The trials are authorised and focus on adults with different cancer types, including advanced solid tumors, high-risk bladder cancer, and urothelial carcinoma.
Study in advanced solid tumors
The first study is titled MK-3120-002 and includes people with advanced or metastatic solid tumor disease.
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.
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.
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.
This trial includes 46 participants and studies SKB410 given by intravesical use, which means it is placed directly into the bladder.
The study aims to evaluate the safety and tolerability of I-VESIC SKB410 monotherapy.
Its main endpoints include dose-limiting toxicity, adverse events, and treatment stop rates because of adverse events.
Study in urothelial cancer
The third study is titled MK-3475-04D and is for people with urothelial carcinoma.
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.
The study looks at safety and tolerability of the combination and also measures Objective Response Rate (ORR) by investigator assessment using RECIST 1.1.
ORR is an early measure of how many people have a tumor response, such as shrinkage or disappearance of cancer on scans.
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.
One study also measures dose-limiting toxicity, which helps show whether a treatment side effect is severe enough to limit use.
The urothelial cancer study adds a response endpoint, ORR, so researchers can see whether the cancer shows an early treatment response.
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.
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.
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.