Funding a Phase 1/2 Clinical Trial Evaluating Volasertib for Several Pediatric Cancers
About Volasertib
Volasertib is a PLK1 inhibitor that blocks cancer cell division. First developed by Boehringer Ingelheim for adult leukemia, it showed tolerability in both adults and children. Licensed to Oncoheroes Biosciences, it is now being advanced for childhood cancers, with preclinical studies showing strong potential in combination with vinorelbine across multiple tumor types.
About the Trial
Ein Herz für Kinder INFORM2 VolVin, led by Hopp Children’s Cancer Center Heidelberg (KiTZ), is an exploratory multinational, multi-arm Phase 1/2 basket trial evaluating volasertib in combination with vinorelbine for children and adolescents with relapsed, refractory, or progressive tumors.
Design
Seamless Phase 1/2, four trial arms (rhabdomyosarcoma, Ewing sarcoma, medulloblastoma+ neuroblastoma, DMG-DIPG), biomarker-driven enrollment.
Primary Goals
Define safe dosing, assess tumor response, and evaluate molecular biomarkers.
Patients
~110 children across multiple cancer types and centers around the world.
Timeline
The trial is expected to begin dosing its first patient in Q4 2025, with signal-generating results that could position volasertib for a registration trial.
Why It Matters
Children with rhabdomyosarcoma (RMS), Ewing sarcoma, medulloblastoma, neuroblastoma, and diffuse midline gliomas (including DIPG) face survival rates below 50%, with few effective treatment options. Existing therapies are highly toxic and leave survivors with lifelong health complications. Volasertib offers new hope for these children.
Be Part of the Cure
With your support, Volasertib can progress through pediatric development and move closer to becoming a life-saving option for children who urgently need better therapies.