A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients
with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose
have been determined (phase I trial).
Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating
study design assessing two dose levels of JX594 when prescribed in combination with
metronomic cyclophosphamide.
Phase II trials with two treatments strategies:
Metronomic CP + JX-594: phase II study sarcoma: this is a monocentric, randomized two-arm non
comparative phase 2 study assessing efficacy and safety of JX-594 in association with
metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma.
Metronomic CP + JX-594: phase II study breast cancer: this is a monocentric, single-arm phase
II study, assessing efficacy and safety of JX-594 in association with metronomic
cyclophosphamide in patients with advanced breast cancer.
Metronomic CP + JX-594 + Avelumab: phase II study sarcoma: this is a monocentric, single arm
phase II study assessing efficacy and safety of avelumab in combination with IT JX-594 and
metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma.
Metronomic CP + JX-594 + Avelumab:: phase II study breast cancer: this is a monocentric,
single-arm phase II study, assessing efficacy and safety of avelumab in combination with IT
JX-594 and metronomic cyclophosphamide in patients with advanced breast cancer.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Institut Bergonié
Collaborators:
Fondation ARC Merck Sharp & Dohme Corp. National Cancer Institute, France Transgene