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HC-7366 · 1 trial · 1 indication
To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology irrespective of VHL gene mutation status
| Arm | Type | Description |
|---|---|---|
| Monotherapy | EXPERIMENTAL | Participants will receive HC-7366 monotherapy \[dose to be determined\] daily |
| Combination | EXPERIMENTAL | Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily |
| Name | Type | Description |
|---|---|---|
| HC-7366 | DRUG | HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator. |
| Belzutifan | DRUG | Belzutifan is a potent and selective HIF-2α inhibitor |
Inclusion Criteria: * Has diagnosis of locally advanced (inoperable) or metastatic RCC with a predominant clear cell component * Be age 18 years or older (male or female) at the time of consent
HC-7366 is an investigational small molecule being studied for the treatment of Renal Cell Carcinoma. It is currently in Phase 1 clinical development, and the ongoing trial evaluates HC-7366 in combination with belzutifan (WELIREG) in patients with this type of cancer.
HC-7366 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of HC-7366 in combination with belzutifan for Renal Cell Carcinoma.
HC-7366 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The current Phase 1 trial is recruiting participants with Renal Cell Carcinoma in the United States.
HC-7366 is being studied in a single Phase 1 clinical trial with the identifier NCT06234605. This trial is titled 'A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma' and is currently recruiting participants in the United States.
Yes, the Phase 1 clinical trial of HC-7366 (NCT06234605) is a controlled trial. It is not randomized or double-blind, and it enrolls approximately 80 participants aged 18 years and older with Renal Cell Carcinoma. The trial is biomarker-selected.