Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Vaxiion Therapeutics
Study ID
NCT05901285
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VAX014 — DRUG
    Intratumorally administered oncolytic agent comprised of recombinant bacterial minicells. VAX014 is not infectious and is not capable of replication
  • Nivolumab or pembrolizumab — COMBINATION_PRODUCT
    VAX014 will be given in combination with Investigator's choice of nivolumab or pembrolizumab.

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VAX014 (Dose Escalation)
    Dose escalation of VAX014 \[recombinant bacterial minicells (rBMCs)\] intratumoral injections alone for subjects with solid tumors relapsed and/or refractory to standard treatment and appropriate for injection of a nodal, subcutaneous, or cutaneous tumor via palpation or with the assistance of ultrasound.
  • Experimental: VAX014 in Combination with Either Nivolumab or Pembrolizumab (Dose Expansion)
    Dose expansion of VAX014 \[recombinant bacterial minicells (rBMCs)\] intratumoral injections in combination with Investigator's choice of nivolumb or pembrolizumab for subjects with solid tumors relapsed and/or refractory to standard treatment and appropriate for injection of a nodal, subcutaneous, or cutaneous tumor via palpation, with the assistance of ultrasound, or interventional radiology.

Primary Outcome Measure

Maximum tolerated dose (MTD) of VAX014 [ Time Frame: up to 21 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85719
Spencer Williams
[email protected]
520-621-1508
Sarah Cannon Research Institute at HealthONEDenverColorado80218
General Contact
[email protected]
720-754-2610
George Washington UniversityWashington D.C.District of Columbia20052
Alyssa Barnett
[email protected]
202-994-0246
Dana Farber Cancer InstituteBostonMassachusetts02215
DFCI Referral Team
[email protected]
857-215-0180
Dartmouth Cancer CenterLebanonNew Hampshire03756
General Contact
[email protected]
(603) 653-3615
Atlantic Health SystemMorristownNew Jersey07960
Maureen Nowakowski
[email protected]
973-971-5569
Cleveland ClinicClevelandOhio44195
Cancer Answer Line
216-444-7923

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZSarah Cannon Research Institute at HealthONE· Denver, COGeorge Washington University· Washington D.C., DCDana Farber Cancer Institute· Boston, MADartmouth Cancer Center· Lebanon, NHAtlantic Health System· Morristown, NJ

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