Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
Vaxiion Therapeutics
Summary
The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.
Description
This study will evaluate the safety and tolerability of VAX014 using a 3+3 dose escalation design to determine a maximum tolerated dose (MTD) or maximum practical dose (MPD) of single agent VAX014. The DLT assessment period will be the initial 21-days of injections. Subjects will receive weekly injections for the initial 8 weeks. Up to six dose levels will be evaluated (i.e., \[starting dose\], \[starting dose\] x 3, \[starting dose\] x 10, \[starting dose\] x 30, \[starting dose\] x 100, \[starting dose\] x 300). Subjects may continue on treatment following discussion between the Principal I…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18+ 2. Informed consent 3. Histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor 4. Progression following at least one prior standard treatment or intolerant of standard treatments. 5. \[Dose Escalation\] Availability of archival or fresh tumor tissue 6. \[Expansion\] Willing to undergo biopsy of the tumor to be injected prior to the initial VAX014 injection (may provide archival tissue instead if approved by Medical Monitor) 7. No available SOC therapy that would confer clinical benefit 8. \[Dose escalation\] At least…
Interventions
- DrugVAX014
Intratumorally administered oncolytic agent comprised of recombinant bacterial minicells. VAX014 is not infectious and is not capable of replication
- Combination ProductNivolumab or pembrolizumab
VAX014 will be given in combination with Investigator's choice of nivolumab or pembrolizumab.
Locations (8)
- University of Arizona Cancer CenterTucson, Arizona
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- George Washington UniversityWashington D.C., District of Columbia
- University of MarylandBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- Dartmouth Cancer CenterLebanon, New Hampshire