Actively Recruiting
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
Led by Vaxiion Therapeutics · Updated on 2026-05-14
48
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to give informed consent
- Confirmed diagnosis of locally advanced or metastatic solid tumor by tissue examination
- Tumor progression after at least one prior standard treatment or intolerance to standard treatments
- Availability of tumor tissue sample for dose escalation phase
- Willingness to undergo tumor biopsy before first VAX014 injection or provide archival tissue for expansion phase
- No standard of care therapy expected to provide clinical benefit
- At least one injectable tumor between 1 and 10 cm for dose escalation phase
- At least one injectable tumor 0.5 cm or larger for expansion phase
- Suitable for treatment with nivolumab or pembrolizumab for expansion phase
- Progression after prior PD-1 immune checkpoint inhibitor treatment for expansion phase
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0, 1, or 2
- Any prior treatment-related toxicity resolved to Grade 1 or less (Grade 2 allowed with approval)
- Adequate blood cell counts (neutrophils, platelets, hemoglobin for expansion phase)
- Adequate liver function (bilirubin, AST, ALT within specified limits)
- Adequate blood clotting function (INR, PT, PTT within specified limits)
- Kidney function with serum creatinine or estimated GFR within acceptable range
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective contraception during treatment and for 3 months after study
You will not qualify if you...
- Tumor too close to critical structures where injection risks swelling causing harm
- Less than 21 days or five half-lives since prior anticancer therapy before first VAX014 injection
- Known brain metastases or leptomeningeal carcinomatosis unless treated and stable off steroids for 14 days
- Severe infection requiring antibiotics or hospitalization
- Need for systemic immunosuppressive therapy above allowed doses
- Active autoimmune disease needing systemic immunosuppressants
- Active lung disease or pneumonitis
- History of severe toxicity to prior PD-1 blockade
- Another cancer likely requiring treatment within next 2 years (exceptions apply)
- Active infections such as tuberculosis or HIV
- Active Hepatitis B or C infection
- Pregnant or breastfeeding women
- Significant heart problems including recent heart attack, unstable angina, or severe heart failure
- Abnormal ECG with prolonged QT interval beyond gender-specific limits
- Medical or psychological conditions posing undue risk for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
George Washington University
Washington D.C., District of Columbia, United States, 20052
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
6
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
K
Kirsten Dorr, IMBA
CONTACT
K
Kate Peters, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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