In short
Clinical trials involving Human Vaccinia Immunoglobulin are being studied as part of a cancer research program that also includes BT-001 and pembrolizumab. These trials look at safety, tolerability, and early signs of benefit in people with advanced solid tumors such as melanoma, breast cancer, lung cancer, sarcoma, and Merkel cell carcinoma.
Key points
- Clinical trial data for Human Vaccinia Immunoglobulin are linked to a Phase 1/2 cancer study that also includes BT-001 and pembrolizumab. The study focused on people with metastatic or advanced solid tumors, including soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, and non-small cell lung cancer. The main goals were to assess safety, tolerability, and early anti-tumor activity. Researchers measured adverse events, dose-limiting toxicities, serious adverse events, progression free rate, and immune overall response rate. The listed trial was completed and enrolled 30 people.
Trial overview
The source data describe one interventional study, which means researchers gave the study treatment to participants and then measured the results. Human Vaccinia Immunoglobulin was listed in the intervention set as Vaccinia Immunoglobulin Intravenous (Human) [VIGIV]. The trial title focused on BT-001 alone and in combination with pembrolizumab in metastatic or advanced solid tumors.
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. 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).
- Soft tissue sarcoma (STS) is a cancer that starts in soft tissues such as muscle, fat, or connective tissue.
- Merkel cell carcinoma (MCC) is a rare and fast-growing skin cancer.
- Melanoma is a cancer that begins in pigment-making skin cells.
- Triple negative breast cancer (TNBC) is a breast cancer subtype that lacks three common receptors used to guide treatment choices.
- Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.
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. 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. Phase I Part B looked at BT-001 with pembrolizumab, and Phase II studied the anti-tumor activity of the combination treatment.
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. The Phase I part also looked at local and systemic safety, meaning side effects at the injection site and effects on the whole body.
What the trial measured
The main outcome measures focused first on safety and then on cancer response. In Phase I, researchers measured the overall incidence of adverse events, dose-limiting toxicities, and serious adverse events. These are standard ways to see whether a treatment is safe enough to continue studying.
For Phase IIa, the trial used different response measures depending on the cancer group. 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. 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.
Study status and size
The trial status was listed as completed. The enrollment number was 30, so the study included 30 participants in total. This was a relatively small early-stage study, which is typical for Phase 1/2 research.