Table of contents
- Trial overview
- Who the study patients were
- Trial phase and study design
- What the trial measured
- Study status and size
Trial overview
The source data describe one interventional study, which means researchers gave the study treatment to participants and then measured the results.[1] Human Vaccinia Immunoglobulin was listed in the intervention set as Vaccinia Immunoglobulin Intravenous (Human) [VIGIV].[1] The trial title focused on BT-001 alone and in combination with pembrolizumab in metastatic or advanced solid tumors.[1]
Who the study patients were
The trial targeted people with metastatic or advanced solid tumors, meaning cancers that had spread or were already at a later stage.[1] The listed cancer types were soft tissue sarcoma (STS), Merkel cell carcinoma (MCC), melanoma, triple negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC).[1]
- Soft tissue sarcoma (STS) is a cancer that starts in soft tissues such as muscle, fat, or connective tissue.[1]
- Merkel cell carcinoma (MCC) is a rare and fast-growing skin cancer.[1]
- Melanoma is a cancer that begins in pigment-making skin cells.[1]
- Triple negative breast cancer (TNBC) is a breast cancer subtype that lacks three common receptors used to guide treatment choices.[1]
- Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.[1]
Trial phase and study design
This study was in Phase 1/2, which combines early safety testing with an early look at whether the treatment may help against cancer.[1] The brief summary says Phase I Part A studied BT-001 as a single treatment with repeated intratumoral dosing, meaning it was given directly into the tumor more than once.[1] Phase I Part B looked at BT-001 with pembrolizumab, and Phase II studied the anti-tumor activity of the combination treatment.[1]
The summary also states that the Phase I part aimed to find the Maximum Tolerated Dose (MTD), which is the highest dose that can be given without causing too many serious side effects.[1] The Phase I part also looked at local and systemic safety, meaning side effects at the injection site and effects on the whole body.[1]
What the trial measured
The main outcome measures focused first on safety and then on cancer response.[1] In Phase I, researchers measured the overall incidence of adverse events, dose-limiting toxicities, and serious adverse events.[1] These are standard ways to see whether a treatment is safe enough to continue studying.[1]
For Phase IIa, the trial used different response measures depending on the cancer group.[1] In the soft tissue sarcoma group, the main measure was progression free rate at 6 months according to iRECIST, which checks how many people did not have cancer growth or worsening by that time.[1] In all other groups except soft tissue sarcoma, the main measure was immune overall response rate according to iRECIST, which looks at how many people had a measurable improvement in their cancer under immune-based rules.[1]
Study status and size
The trial status was listed as completed.[1] The enrollment number was 30, so the study included 30 participants in total.[1] This was a relatively small early-stage study, which is typical for Phase 1/2 research.[1]
