drugset / Trial / NCT03387085
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.
Timeline
- Start
- 2018-03-19
- Primary completion
- 2020-09-11
- Completion
- 2024-01-16
Outcome
Outcome not reported
Stopped: “Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Aldoxorubicin | Small molecule | — | — |
| Background | Avelumab | Monoclonal antibody | — | — |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | ETBX-011 | Vaccine | — | — |
| Background | ETBX-051 | Vaccine | — | — |
| Background | ETBX-061 | Vaccine | — | — |
| Background | GI-4000 | Vaccine | — | — |
| Background | GI-6207 | Vaccine | — | — |
| Background | GI-6301 | Vaccine | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | N-803 | Protein / enzyme biologic | — | — |
| Background | Nab-paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |
| Background | haNK for Infusion | Cell therapy | — | — |