Phase 1 Study of VAX014 for Advanced Solid Tumors
This study is testing VAX014, a non-infectious, non-replicating bacterial treatment, for advanced solid tumors. It will be given directly into the tumor (intratumorally). The study aims to find the safest dose of VAX014 alone, and then test it in combination with either nivolumab or pembrolizumab, which are checkpoint inhibitors (drugs that help your immune system fight cancer). You could join if you are 18 or older, have an advanced solid tumor that has progressed after other treatments or if you can't tolerate standard treatments. The main goals are to see how safe VAX014 is and what dose works best. The current recruitment status is unclear.
- Study design
- This is a Phase 1 study with an unclear status, planning to enroll 48 participants. It will first test VAX014 alone to find the best dose, then combine it with nivolumab or pembrolizumab.
- What's involved
- You would receive weekly injections of VAX014 for the first 8 weeks. The study will monitor your safety and tolerability for an average of 20 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be monitored through study completion, which is an average of 20 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
At a glance
Conditions
NCT05901285
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atlantic Health System
Morristown, New Jerseystudy coordinator listed
Recruiting
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Dana Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
Dartmouth Cancer Center
Lebanon, New Hampshirestudy coordinator listed
Recruiting
George Washington University
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
Melanoma & Skin Cancer Institute
Denver, Coloradostudy coordinator listed
Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Coloradostudy coordinator listed
Recruiting
University of Arizona Cancer Center
Tucson, Arizonastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Maximum tolerated dose (MTD) of VAX014up to 21 days
The MTD will be defined as the dose level at which at most one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT
- Incidence of Treatment-Emergency Adverse Events (Safety and Tolerability)Through study completion, an average of 20 weeks
Toxicities will be assessed in each subject by tracking the occurrence of graded Adverse Events (AEs). AEs will be graded according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v5.0
- Recommended Phase 2 Dose (RP2D) for single agent intratumoral VAX014up to 5 weeks
The RP2D will be determined following the determination of the MTD and with agreement by the Safety Review Committee
- Acceptable dose of VAX014 in combination with PD-1 Inhibitor3 months
Determine the acceptable dose of VAX014 when used in combination with Investigator's choice of nivolumab or pembrolizumab
- Evaluation of efficacy of VAX014 in combination with either nivolumab or pembrolizumab18 months
Evaluate efficacy including overall response rate (ORR), response of injected tumor(s) of VAX014 in combination with Investigator's choice of nivolumab or pembrolizumab