Kidney Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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
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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT06234605

Recruitment Status:

Recruiting

Sponsor:

HiberCell, Inc.

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There are 3 Locations for this study

See Locations Near You

University of California San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Rana McKay
Contact
HealthPartners Cancer Research Center
Saint Paul Minnesota, 55101, United States More Info
Brian Rank
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Neil Shah
Contact

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT06234605

Recruitment Status:

Recruiting

Sponsor:


HiberCell, Inc.

How clear is this clinincal trial information?

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