A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Subjects with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma

Objective:

Primary Objectives:

• 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 or metastatic RCC with predominantly clear cell histology (ccRCC), irrespective of VHL gene mutation status (combination only).

Secondary Objectives:

• To assess the potential antitumor activity of HC-7366 in combination with belzutifan by response, disease stabilization, and survival outcomes by assessing:
  • 1. Overall response rate (ORR) per RECIST v1.1
  • 2. Duration of response (DOR)
  • 3. Disease control rate (DCR: CR or PR or stable disease)
  • 4. Time to Response (TTR)
  • 5. Median progression free survival (PFS) and PFS at six months
  • 6. Median overall survival (OS) and 1-yr OS
• To determine the plasma concentration and PK parameters following single and multiple doses of HC-7366 alone or in combination with belzutifan administered to patients with locally advanced or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status (PK parameters of both HC-7366 and belzutifan will be measured)
• To characterize HC-7366 monotherapy and in combination with belzutifan in patients with ccRCC