Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VAX014 · 1 trial · 2 indications
The MTD will be defined as the dose level at which at most one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT
Toxicities will be assessed in each subject by tracking the occurrence of graded Adverse Events (AEs). AEs will be graded according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v5.0
The RP2D will be determined following the determination of the MTD and with agreement by the Safety Review Committee
Determine the acceptable dose of VAX014 when used in combination with Investigator's choice of nivolumab or pembrolizumab
Evaluate efficacy including overall response rate (ORR), response of injected tumor(s) of VAX014 in combination with Investigator's choice of nivolumab or pembrolizumab
| Arm | Type | Description |
|---|---|---|
| VAX014 (Dose Escalation) | EXPERIMENTAL | 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. |
| VAX014 in Combination with Either Nivolumab or Pembrolizumab (Dose Expansion) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion 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 arch...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |