RecruitingAdvanced Solid TumorAdvanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Vaxiion Therapeutics
You may qualify if…
- ✓ 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 one cutaneous, subcutaneous, or nodal injectable tumor (between 1 and 10 cm in largest diameter) that can be injected by direct palpation or with the assistance of ultrasound without the need for interventional radiology
You may not qualify if…
- ✕ 1. Injectable tumor not sufficiently distanced from critical structures (e.g., major airway, neurovascular structure) where post injection swelling may place the subject at unacceptable risk
- ✕ 2. ≤ 21 days or ≤ five half-lives (whichever is shorter) between any prior anticancer therapy (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation) and the first injection of VAX014
- ✕ 3. Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from the first injection of VAX014
- ✕ 4. Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection
- ✕ 5. Need for systemic immunosuppressive therapy (≤10 mg of prednisone equivalent, or one time pulse steroids excepted)
- ✕ 6. Active autoimmune disease requiring systemic immunosuppressive therapy
- ✕ 7. Active lung disease or pneumonitis
- ✕ 8. History of Grade 4 toxicity in response to prior PD-1 blockade
Where it's recruiting
Arizona
Tucson
Colorado
Denver
District of Columbia
Washington D.C.
Massachusetts
Boston
New Hampshire
Lebanon
New Jersey
Morristown
Ohio
Cleveland
Source: ClinicalTrials.gov · NCT05901285 · last updated 2026-08-24