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HC-7366

DRUG4 trials

Sponsors

HiberCell, Inc., M.D. Anderson Cancer Center

Conditions

Acute Myeloid LeukemiaClear Cell Renal Cell CarcinomaColo-rectal CancerHC-7366Kidney CancerNon Small Cell Lung CancerOther Solid TumorsPhase 1b

Phase 1

A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
TerminatedNCT05121948
HiberCell, Inc.Clear Cell Renal Cell Carcinoma, Colo-rectal Cancer, Non Small Cell Lung Cancer +3
Start: 2022-02-23End: 2024-03-01Updated: 2024-03-08
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
RecruitingNCT06234605
HiberCell, Inc.Renal Cell Carcinoma
Start: 2024-04-29End: 2027-11-30Target: 80Updated: 2026-01-15
Phase I Study of HC-7366 for Acute Myeloid Leukemia
RecruitingNCT06285890
M.D. Anderson Cancer CenterAcute Myeloid Leukemia
Start: 2024-05-20End: 2029-12-31Target: 18Updated: 2026-08-10
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
RecruitingNCT07401875
M.D. Anderson Cancer CenterHC-7366, Kidney Cancer, Phase 1b +1
Start: 2026-03-24End: 2029-11-30Target: 35Updated: 2026-09-01

Related Papers

Pharmacokinetics and pharmacodynamics of the GCN2 activator HC-7366 in a phase 1a study in patients with advanced solid tumors.
Journal of Clinical Oncology2026-05-28
A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic renal cell carcinoma.
Journal of Clinical Oncology2026-05-27
Combining HC-7366 with belzutifan in patients with renal cell carcinoma to alter tumor and microenvironment: Pharmacokinetic and pharmacodynamic (PK/PD) analysis of a phase 1b study.
Journal of Clinical Oncology2026-05-27
Abstract 6485: Combination of the GCN2 activator HC-7366 with VEGFR-TKI results in greater efficacy than VEGFR-TKI alone or VEGFR-TKI/HIF-2i combinations in ccRCC
Cancer Research2026-04-03
Phase 1b study of HC-7366 alone and in combination with venetoclax and azacitidine in relapsed/refractory Acute Myeloid Leukemia
Blood2025-11-03
A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with advanced or metastatic renal cell carcinoma (NCT06234605).
Journal of Clinical Oncology2025-05-281 citations
A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with advanced or metastatic renal cell carcinoma (NCT06234605).
Journal of Clinical Oncology2025-02-10
Abstract 4615: HC-7366, a potent GCN2 activator, complements belzutifan, a HIF-2⍺ antagonist, by providing combination benefit in belzutifan-sensitive models and monotherapy activity in belzutifan-resistant models
Cancer Research2024-03-22
Abstract 4666: HC-7366, a potent GCN2 kinase activator, augments osimertinib therapy to delay resistance in EGFR mutant NSCLC models
Cancer Research2024-03-22
Activation of GCN2 By HC-7366 Results in Significant Anti-Tumor Efficacy As Monotherapy and Overcomes Resistance Mechanisms When Combined with Venetoclax in AML
Blood2023-11-023 citations
Abstract A30: Activation of GCN2 by HC-7366 results in significant anti-tumor efficacy as monotherapy and in combination with Venetoclax in AML models
Blood Cancer Discovery2023-05-01
Abstract 6231: Activation of GCN2 by HC-7366 results in significant antitumor efficacy as monotherapy and in combination with multiple standard of care agents in various solid cancer models
Cancer Research2023-04-043 citations
1327 Novel GCN2 modulator HC-7366 decreases pulmonary metastases and reduces myeloid-derived suppressor cells
Regular and Young Investigator Award Abstracts2022-11-015 citations
A multicenter, open-label, phase 1a/b study of HC-7366, a modulator of integrated stress response (ISR) kinase GCN2 in subjects with advanced solid tumors.
Journal of Clinical Oncology2022-06-011 citations