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

HC366-RCC2311

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.

2024-04-29

2026-11-01

2027-11-01

Recruiting

Early phase I

80

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 * Patients with progressive disease after receipt of at least 2 and no more than 5 prior lines of therapy for metastatic (stage IV) disease, including but not limited to VEGF-directed tyrosine kinase inhibitors (TKIs), high-dose IL-2, immune checkpoint inhibitors, or Mtor inhibitors alone or in combination. * Has adequate organ function * Has ECOG performance score of 0-1 * Has at least one measurable lesion as per RECIST 1.1. * Has a life expectancy of 3 months or greater as determined by the treating physician. Exclusion Criteria: * Has received prior treatment with belzutifan or another HIF-2α inhibitor * Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤2 weeks before allocation. * Has received any type of systemic anticancer antibody (including investigational antibody) ≤4 weeks before allocation. * Has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment * Has had history of major surgery \< 3 weeks before allocation * Has received prior radiotherapy within 2 weeks before allocation * Have clinically significant cardiovascular disease within 6 months from first dose of study drug administration * Has known additional malignancy that is progressing or required active treatment within the past 5 years * Has a history of or known active central nervous system metastases and/or carcinomatous meningitis * Is unable to swallow orally administered medication intact or has a history or current evidence of a gastrointestinal disorder * Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections * Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, or interfere with the individual's ability to cooperate with the requirements of the study * Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 90 days after the final administration of the study drug.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-05-01