The dose escalation (Phase I) is expected to begin in 2026, with the objective of characterizing all effects of HEPHA-440 on the body and determining a safe and effective dose for Phase II, known as RP2D (Recommended Dose for Phase II trial).
The two Phase II trials are expected to begin in 2027:
- The efficacy of the drug alone at the RP2D dose will be evaluated in 18 patients with osteosarcoma, a bone cancer that primarily affects children and adolescents.
- The efficacy of HEPHA-440 in combination with other immunotherapies (so-called “immune checkpoint inhibitors”) will be tested in a cohort of 25 patients with various other solid tumors.
The clinical trials will take place at the Hospices Civils de Lyon (HCL), the study sponsor, as well as at the Léon Bérard Center (CLB). In addition to these hospitals, the NetSarc network will be mobilized to recruit patients for the Phase II osteosarcoma trial, given the low prevalence of this type of cancer. The clinical trial protocols and results will be available on the clinicaltrials.gov website.
