RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-02

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05901285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 9. \[Expansion\] At least one injectable tumor (\>=0.5cm in largest diameter) that can be injected either with or without the need for interventional radiology 10. \[Expansion\] Appropriate for treatment with either nivolumab or pembrolizumab 11. \[Expansion\] Progression following at least one prior regimen containing PD-1 directed immune checkpoint blockade 12. Measurable disease by RECIST v1.1 13. ECOG Performance Status of 0, 1, or 2 14. Resolution of any toxicity associated with prior therapy to ≤ Grade 1 (Residual toxicity of Grade 2 may be allowed following discussion with Medical Monitor) 15. Adequate hematologic function defined as: 1. Absolute neutrophil count \>=1,500/uL 2. Platelet count \>=100,000/uL 3. \[Expansion\] Hemoglobin \>=9 gm/dL 16. Adequate hepatic function defined as: 1. Total bilirubin ≤ 1.5 x ULN 2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN 117. Adequate coagulation defined as: 1. International normalized ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN 2. Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN 18. Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min/1.73 m2 (per MDRD GFR formula) 19. Women of childbearing potential must have a negative serum pregnancy test 20. All subjects of childbearing potential must be willing to consent to using effective contraception (as determined by the Investigator) while on treatment and for 3 months after their participation in the study ends	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 from prior anticancer therapy and C1D1 (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation therapy) 3. Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from C1D1 4. Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection within 2 weeks of the first injection of VAX014 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. No active lung disease or pneumonitis 8. No history of Grade 4 toxicity in response to prior PD-1 blockade 9. Any other malignancy likely to require treatment in the next 2 years (exceptions include cancer such as basal or squamous cell skin cancers, noninvasive cancer of the cervix, and local prostate cancer) 10. Known active infection with tuberculosis or HIV 11. Active Hepatitis B or C 12. \[Females\] pregnant or breastfeeding 13. Clinically significant cardiovascular abnormalities including: 1. ≤ 12 months from prior MI 2. Unstable angina pectoris 3. ≤ 6 months from NYHA classification \>3 CHF 10. Medical or psychological condition that places the subject at undue risk with study participation

Inclusion Criteria

Exclusion 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 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
9. \[Expansion\] At least one injectable tumor (\>=0.5cm in largest diameter) that can be injected either with or without the need for interventional radiology
10. \[Expansion\] Appropriate for treatment with either nivolumab or pembrolizumab
11. \[Expansion\] Progression following at least one prior regimen containing PD-1 directed immune checkpoint blockade
12. Measurable disease by RECIST v1.1
13. ECOG Performance Status of 0, 1, or 2
14. Resolution of any toxicity associated with prior therapy to ≤ Grade 1 (Residual toxicity of Grade 2 may be allowed following discussion with Medical Monitor)
15. Adequate hematologic function defined as:
1. Absolute neutrophil count \>=1,500/uL
2. Platelet count \>=100,000/uL
3. \[Expansion\] Hemoglobin \>=9 gm/dL
16. Adequate hepatic function defined as:
1. Total bilirubin ≤ 1.5 x ULN
2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
117. Adequate coagulation defined as:
1. International normalized ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN
2. Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN 18. Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min/1.73 m2 (per MDRD GFR formula) 19. Women of childbearing potential must have a negative serum pregnancy test 20. All subjects of childbearing potential must be willing to consent to using effective contraception (as determined by the Investigator) while on treatment and for 3 months after their participation in the study ends

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 from prior anticancer therapy and C1D1 (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation therapy)
3. Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from C1D1
4. Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection within 2 weeks of the first injection of VAX014
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. No active lung disease or pneumonitis
8. No history of Grade 4 toxicity in response to prior PD-1 blockade
9. Any other malignancy likely to require treatment in the next 2 years (exceptions include cancer such as basal or squamous cell skin cancers, noninvasive cancer of the cervix, and local prostate cancer)
10. Known active infection with tuberculosis or HIV
11. Active Hepatitis B or C
12. \[Females\] pregnant or breastfeeding
13. Clinically significant cardiovascular abnormalities including:
1. ≤ 12 months from prior MI
2. Unstable angina pectoris
3. ≤ 6 months from NYHA classification \>3 CHF
10. Medical or psychological condition that places the subject at undue risk with study participation

Contacts and Locations

Study Contact

Kirsten Dorr, MBA

CONTACT

858-630-1959

kdorr@sciquus.com

Gabriela Sanchez, BS

CONTACT

858-630-1960

gsanchez@sciquus.com

Study Locations (Sites)

University of Arizona Cancer Center

Tucson, Arizona, 85719

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

United States

George Washington University

Washington, District of Columbia, 20052

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Atlantic Health System

Morristown, New Jersey, 07960

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Vaxiion Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02

Study Completion Date2026-11

Study Record Updates

Study Start Date2023-11-02

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

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