In December 2023, Merck and HiberCell announced that the organizations would be partnering on a Phase 1b clinical study to examine a drug combination for clear cell renal cell carcinoma (RCC). Phalguni Deswal reports in Clinical Trials Arena that the study will focus on understanding how safe, effective, and well-tolerated the combination of Welireg (belzutifan) and HC-7366 are.
Welireg was initially FDA-approved for the treatment of adults with von Hippel-Lindau disease who required therapy for associated central nervous system (CNS) hemangioblastoma, pancreatic neuroendocrine tumors, or renal cell carcinoma. More recently, Welireg was approved for adults with relapsed/refractory RCC who haven’t responded to PD-1 or PD-L1 inhibitors and who have been treated with VEGF-TK1. HC-7366 is a selective GCN2 kinase activator with anti-tumor properties. Learn more about HC-7366 here.
An estimated 80 individuals will enroll in the Phase 1b study. During the course of the study, researchers will focus on:
- Dose-escalation and dose-expansion. In this phase, researchers will identify the dose limits, as well as the ideal dose for future research.
- A cohort which solely focuses on HC-7366. For this portion, researchers will study HC-7366 as a monotherapy, though the rest of the trial will focus on the combination treatment.
Learn About Renal Cell Carcinoma (RCC)
Renal cell carcinoma is a type of kidney cancer; clear cell RCC is the most common subtype. Typically, this cancer manifests in one kidney but it may spread throughout the body to other organs. Though rare, RCC is the most common form of kidney cancer in adults. It is more common in males and those between 50 to 70 years old. PRC, TFE 3, and VHL gene mutations have been linked to RCC. In early stages, some individuals may not display symptoms. When symptoms appear, these can include fatigue, high blood pressure, vision abnormalities, fever, enlarged testicle(s), blood in the urine (hematuria), unintended weight loss, and abdominal pain.
Sorafenib, Proleukin, and Afinitor have all been approved to treat RCC. Beyond that, patients may undergo surgery, chemotherapy, ablation, or hormone treatments to address the tumors. If you have RCC, please speak with your care team to identify your best mode of treatment.
