A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

HiberCell

Status and phase: Enrolling; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: HC-7366; Drug: Belzutifan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06234605

MK-6482-030 (Other Identifier)

HC366-RCC2311

Details and patient eligibility

About

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Monotherapy

Experimental group

Description:

Participants will receive HC-7366 monotherapy \[dose to be determined\] daily

Treatment:

Drug: HC-7366

Combination

Experimental group

Description:

Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily

Treatment:

Drug: Belzutifan

Drug: HC-7366