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

ConditionRenal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHiberCell, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: MonotherapyExperimental treatment 1 intervention
Group B: CombinationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determination of MTD and RP2D (combination cohorts only)

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

Time frame
30 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HiberCell, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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