Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06234605 | A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma | PHASE1 | RECRUITING | 80 | — | — | Apr 29, 2024 | Nov 1, 2027 | Jan 15, 2026 | 20 | United States |
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
| Arm | Type | Description |
|---|---|---|
| Monotherapy | EXPERIMENTAL | Participants will receive HC-7366 monotherapy \[dose to be determined\] daily |
| Combination | EXPERIMENTAL | Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily |
| Name | Type | Description |
|---|---|---|
| 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 |
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