Clinical trials: HIF-2α
Healthy Participants
Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers
This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic profile, and drug-drug interaction (DDI) of casdatifan in healthy participants.
- Trial name
- ARC-14 (NCT05117554)
- Testing
- casdatifan, Midazolam
- Where
- Netherlands
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Renal Cell Carcinoma
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced…
- Trial name
- NCT05468697
- Testing
- Belzutifan, Palbociclib
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell…
- Trial name
- NCT05239728
- Testing
- Belzutifan, Pembrolizumab
- Where
- 285 sites in United States, Australia and 30 more
- Volunteers
- 1,800 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumors, Solid Tumor
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
The primary objective of this study is to identify the maximum tolerated dose (MTD) of belzutifan Tablets and/or the recommended Phase 2 dose (RP2D) of belzutifan Tablets in patients with advanced solid tumors
- Conditions
- Advanced Solid Tumors, Solid Tumor, Solid Carcinoma, Solid Tumor, Adult
- Trial name
- NCT02974738
- Testing
- Belzutifan
- Volunteers
- 120 people
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
- Trial name
- NCT04846920
- Testing
- Belzutifan
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Merck Sharp & Dohme LLC
ccRCC, RCC
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of MK-3795, formerly called PT2385 and/or the recommended Phase 2 dose (RP2D) of MK-3795 in patients with advanced clear cell renal cell…
- Conditions
- ccRCC, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma
- Trial name
- NCT02293980
- Testing
- MK-3795, Nivolumab, Cabozantinib
- Where
- 25 sites in United States
- Volunteers
- 110 people
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy Participants
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the…
- Trial name
- NCT07641881
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Healthy Participants
Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)
The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong…
- Trial name
- NCT06919991
- Testing
- Casdatifan, Itraconazole, Phenytoin
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded…
- Trial name
- NCT04195750
- Testing
- Belzutifan, Everolimus
- Where
- 172 sites in United States, Brazil and 21 more
- Volunteers
- 755 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC)
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC.
- Conditions
- Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC), Kidney Cancer, Renal Cancer
- Trial name
- NCT03634540
- Testing
- Belzutifan, Cabozantinib
- Where
- 10 sites in United States
- Volunteers
- 118 people
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated…
- Conditions
- Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Advanced Gastrointestinal Stromal Tumor
- Trial name
- NCT04924075
- Testing
- Belzutifan
- Where
- 84 sites in United States, Australia and 20 more
- Volunteers
- 355 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Clear Cell Renal Cell Carcinoma
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell…
- Trial name
- eVOLVE-RCC02 (NCT07000149)
- Testing
- Volrustomig, Casdatifan
- Where
- 3 sites in Australia, South Korea
- Volunteers
- 9 people
- Sponsor
- AstraZeneca
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.
- Trial name
- NCT04489771
- Testing
- Belzutifan
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 154 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the…
- Trial name
- NCT07011719
- Testing
- Casdatifan, Cabozantinib
- Where
- 183 sites in United States, Argentina and 15 more
- Volunteers
- 720 people
- Sponsor
- Arcus Biosciences, Inc.
Renal Cell Carcinoma
A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles, and preliminary efficacy of belzutifan as monotherapy followed by belzutifan+lenvatinib combination therapy, as well…
- Trial name
- NCT05030506
- Testing
- Belzutifan, Pembrolizumab, Lenvatinib
- Where
- 5 sites in China
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Renal Cell Carcinoma
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
- Trial name
- NCT07049926
- Testing
- Belzutifan, Zanzalintinib
- Where
- 33 sites in United States, Chile and 6 more
- Volunteers
- 140 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies
This was a first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer.
- Trial name
- NCT04895748
- Testing
- DFF332, RAD001, PDR001
- Where
- 11 sites in United States, Czechia and 5 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
ccRCC, Clear Cell Renal Cell Carcinoma
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the recommended doses for expansion (RDEs) of NKT2152. The Phase 2 portion will evaluate the efficacy of NKT2152 in ccRCC.
- Conditions
- ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms
- Trial name
- NCT05119335
- Testing
- Oral NKT2152
- Where
- 13 sites in United States
- Volunteers
- 120 people
- Sponsor
- NiKang Therapeutics, Inc.