HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, is pleased to announce the dosing of the first patient in a Phase 1b study evaluating HC-7366, an activator of integrated stress response (ISR) Kinase GCN2, in combination with Merck’s oral hypoxia-inducible factor-2α (HIF-2α) inhibitor WELIREG® (belzutifan) for the treatment of advanced clear cell renal cell carcinoma (ccRCC).

The Phase 1b study (NCT06234605) will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with belzutifan in patients with advanced ccRCC. This trial will also determine a recommended Phase 2 dose (RP2D) of HC-7366 in combination with fixed-dose belzutifan, 120 mg po qd. Dose escalation of HC-7366 in the combination, followed by an expansion phase will optimize dose evaluation. An independent HC-7366 monotherapy cohort is being evaluated in parallel. The study will enroll up to 80 patients at clinical sites across the US. Robert J. Motzer, MD., Section Head, Kidney Cancer, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center (MSK) will be the lead Principal Investigator (PI) for the clinical trial.

"The first patient dosed in this trial marks the beginning of an exciting new chapter in the clinical development of HC-7366," stated Cherry Thomas, M.D., Chief Medical Officer. "The combination of HC-7366 with belzutifan, a key agent for the treatment of clear cell renal cell carcinoma, offers a potentially promising novel and differentiated treatment in a setting with major unmet need and limited treatment options for patients. We recently presented key aspects of the significant preclinical data in support of the combination at the 2024 American Association for Cancer Research Annual Conference."