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

Conditions

• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Apr 29, 2024

Status verified

Jan 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Determination of MTD and RP2D (combination cohorts only) [ Time Frame: 30 months ]

Central Contacts

• Michele Gargano
  651-675-0300
  [email protected]
• Paulette Mattson
  651-675-0300
  [email protected]

Locations (20)

Find similar trials in Tucson, AZ

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