Dongjak, Korea, Republic of
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Phase
3Span
377 weeksSponsor
IpsenNiigata
Recruiting
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Phase
3Span
238 weeksSponsor
Ono Pharmaceutical Co. LtdNiigata
Recruiting
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Phase
3Span
346 weeksSponsor
Ono Pharmaceutical Co. LtdNiigata
Recruiting
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)
To evaluate safety and efficacy of CBA-1205 in the following three parts in a stepwise manner: - In Part 1, safety and tolerability in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined. - In Part 2, safety and tolerability in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined. - In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. - PK analysis
Phase
1Span
265 weeksSponsor
Chiome Bioscience Inc.Niigata
Recruiting
Niigata
Recruiting
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Phase
3Span
278 weeksSponsor
GlaxoSmithKlineNiigata
Recruiting
Niigata
Recruiting
A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
This study consists of two parts and two cohorts: Part A (Phase 1b; Safety Run-in) and Part B (Phase 2; Dose Optimization), Cohort 1 (I-DXd in maintenance) and Cohort 2 (I-DXd in induction + maintenance). The primary objective of this study is to evaluate the safety and tolerability of I-DXd in combination with atezolizumab with or without carboplatin by assessing treatment-emergent adverse events (TEAEs) and other safety parameters which will inform optimal dose selection of I-DXd in the combination regimens (Dose Optimization Part B) of this study.
Phase
1/2Span
128 weeksSponsor
Daiichi SankyoNiigata
Recruiting
A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Phase
3Span
148 weeksSponsor
Eli Lilly and CompanyNiigata
Recruiting
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
This study will evaluate the safety and efficacy of zipalertinib in participants with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or compound Epidermal Growth Factor Receptor Proteins Mutations (EGFRmts). Participants will be enrolled into 1 of the 4 following cohorts: - Cohort A ("prior ex20ins treatment") will include participants harboring EGFR ex20ins who have progressed on or after initial treatment with standard platinum-based chemotherapy and prior treatment with an ex20ins agent for their advanced disease (administered together or separately). - Cohort B ("first-line") will include participants harboring EGFR ex20ins who have not received prior treatment for advanced or metastatic disease and are not appropriate candidates for first-line doublet platinum-based chemotherapy or have refused first-line doublet platinum-based chemotherapy. - Cohort C ("active brain mets") will include participants harboring EGFR ex20ins or other uncommon single or compound EGFRmts and active brain metastases and/or leptomeningeal disease (LMD). Participants may or may not have had prior treatment for advanced disease. - Cohort D ("other uncommon EGFRmts") will include participants harboring other non-ex20ins, excluding C797S (uncommon single or compound) EGFRmts who have not received prior systemic therapy for their locally advanced or metastatic NSCLC disease.
Phase
2Span
162 weeksSponsor
Taiho Oncology, Inc.Niigata
Recruiting