Table of contents
- Trial overview
- Who is being studied
- What the trials measure
- How the studies are designed
- Key Skb264 trials
- Patient-friendly terms
Trial overview
The available studies of Skb264 are all Phase 2 interventional trials, which means researchers are giving the study treatment and then watching what happens. These trials are focused on cancer, not on healthy volunteers.[1][2][3]
Across the listed trials, Skb264 is being studied in advanced non-small cell lung cancer and in several solid tumors, including endometrial, cervical, prostate, urothelial, and ovarian cancer.[1][3]
Who is being studied
One trial includes people with advanced or metastatic non-small cell lung cancer, while another includes patients with metastatic or locally advanced unresectable solid tumors that have progressed after standard therapies.[1][2]
The basket study includes selected solid tumors: endometrial cancer, cervical cancer, prostate cancer, urothelial carcinoma, and ovarian cancer.[3]
These study groups are made up of adults with cancer that is advanced, spread, or hard to treat with usual care.[1][2][3]
What the trials measure
The main safety measures include dose-limiting toxicity, the number of adverse events, and how many people stop treatment because of side effects.[1][3]
The main benefit measure is objective response rate (ORR), which means the share of patients whose tumors have a confirmed complete response or partial response based on RECIST 1.1, a standard way to measure tumor change on scans.[1][2]
In the prostate cancer part of the basket study, researchers also measure whether prostate-specific antigen, a protein made by the prostate, goes down.[3]
How the studies are designed
The lung cancer study is testing Skb264 alone or in combination treatment, and the brief summary says the goal is to evaluate safety, tolerability, and response in advanced or metastatic non-small cell lung cancer.[1]
The completed solid tumor study tested Skb264 as monotherapy, which means treatment with Skb264 alone, in patients whose cancer had already progressed after standard treatment options.[2]
The basket study combines Skb264 with pembrolizumab, another cancer medicine, to see whether the combination is safe and effective in selected solid tumors.[3]
Key Skb264 trials
NCT05816252 is an authorised Phase 2 study in advanced or metastatic non-small cell lung cancer. It plans to enroll 498 participants and measures dose-limiting toxicity, adverse events, treatment stopping because of adverse events, and ORR.[1]
NCT04152499 is a completed Phase 2 study in metastatic or locally advanced unresectable solid tumors that progressed after standard therapies. It enrolled 1,261 participants and looked mainly at ORR by RECIST 1.1.[2]
NCT05642780 is an authorised Phase 2 basket study in endometrial, cervical, prostate, urothelial, and ovarian cancer. It plans to enroll 318 participants and measures safety and efficacy, including tumor response and PSA decrease in prostate cancer.[3]
Patient-friendly terms
Basket study means one trial includes several cancer types at the same time, so researchers can see if the treatment may help more than one group.[3]
Combination treatment means Skb264 is given with another cancer medicine, rather than by itself.[1][3]
Confirmed response means the tumor shrinkage was checked and still counted as a response under the study rules.[1][2]
Hard-to-treat cancer means cancer that did not respond well to standard treatments or has limited treatment options left.[2]
