IRB Study Number 24-280
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1. Primary Objectives
• Evaluate the safety and tolerability of intratumoral VAX014 [AEs, DLTs, laboratory evaluations, exams]
• Determine the Maximum Tolerated Dose (MTD) or Maximum Practical Dose (MPD) [DLTs, overall safety profile]
• Define a RP2D for VAX014 [DLTs, overall safety profile]
2.2. Secondary Objectives
• Characterize systemic exposure by evaluating PK of intratumoral VAX014 [systemic PK] • Evaluate the formation of anti-drug antibodies (ADA) following intratumoral VAX014 [systemic ADA]
• Evaluate efficacy including overall response rate (ORR), response of injected tumor, and response of noninjected tumors [RECIST, iRECIST, itRECIST]
Inclusion Criteria
Age 18+
Informed consent
Histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor
Progression following at least one prior therapy or intolerance of standard treatments
Availability of archival or fresh tumor tissue
No available SOC therapy that would confer clinical benefit
[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
[Expansion] At least one injectable tumor (between 1 and 10 cm in largest diameter) that can be injected either with or without the need for interventional radiology
Measurable disease by RECIST v1.1
ECOG Performance Status of 0, 1, or 2
Resolution of any toxicity associated with prior therapy to ≤ Grade 1 (Residual toxicity of Grade 2 may be allowed following discussion with Medical Monitor)
Adequate hematologic function defined as:
a. Absolute Neutrophil Count (ANC) >1,500/uL
b. Platelet count >100,000/uL
- Adequate hepatic function defined as:
a. Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN if known Gilbert’s disease)
b. Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 2.5 x ULN (or ≤ 5 x ULN in subjects with liver metastasis)
- Adequate coagulation defined as:
a. International normalized ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN
b. Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN
Serum creatinine ≤ 1.5 x ULN or estimated Glomerular Filtration Rate (GFR) ≥ 60 mL/min/1.73 m2 (per MDRD GFR formula)
Women of childbearing potential must have a negative serum pregnancy test
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
Exclusion Criteria
Injectable tumor not sufficiently distanced from critical structures (e.g., major airway, neurovascular structure) where post injection swelling or bleeding may place the subject at unacceptable risk
≤ 21 days between any prior anticancer therapy (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation) and the first injection of VAX014
Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from the first injection of VAX014
Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection within 2 weeks of the first injection of VAX014
Need for systemic immunosuppressive therapy (≤ 10mg of prednisone equivalent, or one time pulse steroids excepted)
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)
Known active Hepatitis B or C
Women who are pregnant or lactating
Clinically significant cardiovascular abnormalities including:
a. ≤ 12 months from prior MI
b. Unstable angina pectoris
c. ≤ 6 months from NYHA classification >3 CHF
- Medical or psychological condition that places the subject at undue risk during study participation
