In short
Clinical trials are investigating Rp1 in people with early-stage triple-negative breast cancer. The studies are looking at safety, side effects, and how well Rp1 works when given with atezolizumab before surgery. The main goal is to see whether this treatment can lower the amount of cancer left at the time of surgery.
Key points
- One clinical trial is studying Rp1 in people with early-stage triple-negative breast cancer. The trial tested Rp1 with atezolizumab before surgery, which is called the neo-adjuvant setting. It included a safety run-in part and then a Phase 2 part. Researchers measured safety, including the type and severity of adverse events, and also measured residual cancer burden at surgery. The trial is listed as completed and enrolled 51 people.
Trial overview
The trial studied Rp1 together with atezolizumab in the neo-adjuvant setting for early-stage triple-negative breast cancer. Neo-adjuvant means treatment given before surgery.
The study title describes this as oncolytic immunotherapy, but the source data mainly show that the trial tested the combination of Rp1 and atezolizumab before surgery in this cancer group.
Who was studied
The trial enrolled patients with early-stage triple-negative breast cancer. This means the study focused on people whose breast cancer was found at an early stage and had the triple-negative type.
The source data do not give the full list of entry rules, so we can only say that the study population was early-stage triple-negative breast cancer patients.
What was tested
The intervention list includes atezolizumab and vusolimogene oderparepvec, which the trial title and summary connect to Rp1. The brief summary says the safety run-in was designed to evaluate the safety and toxicity of the combination Atezolizumab plus RP1 oncolytic immunotherapy.
In simple terms, the researchers were checking whether the treatment combination could be given safely before surgery and whether it might help reduce the amount of cancer left behind.
Study phase and design
This was an interventional study, which means the researchers gave a treatment and then measured what happened. The trial was a Phase 2 study and also included a safety run-in part.
A safety run-in is an early part of a study used to check safety before the main part continues. In this trial, that early step looked at the combination of Atezolizumab plus Rp1.
Main endpoints
The safety run-in endpoint was the incidence, nature, and severity of adverse events, with severity graded using NCI CTCAE v5.0. This means the study counted unwanted medical problems, described what they were, and measured how serious they were.
The Phase 2 endpoint was the residual cancer burden, or RCB 0-1 rate, at the time of surgery in patients with no increase in ctDNA after cycle 3. Residual cancer burden means how much cancer is still present after treatment, and ctDNA is cancer-related DNA found in the blood.
The brief summary adds that the main Phase 2 goal was to measure the rate of RCB 0-1 at definitive surgery in subjects who had completed at least one cycle of treatment.
Trial status and size
The trial is listed as completed. It enrolled 51 participants.
Because the study is completed, the source data focus on the trial plan, target group, and outcome measures rather than final results.