What is a clinical trial?
Before a new drug is released to the market, it takes a long time and a lot of research and testing.
New drugs developed by pharmaceutical companies require approval from the Ministry of Health, Labor and Welfare, and clinical trials are conducted to obtain this approval. Clinical trials are conducted in accordance with standards set by the Ministry of Health, Labor and Welfare (standards for conducting clinical trials of pharmaceuticals). Clinical trials for anticancer drugs have the following stages (phases), and development proceeds in order, with safety and efficacy being confirmed at each stage.
Phase I
We examine how candidate drug substances behave in the body and whether their side effects are tolerable and can be used without problems.
Phase II
A relatively small number of patients are studied to examine the efficacy and safety of a drug candidate.
The dosage and method of administration will be considered.
Phase III
This is a relatively large-scale trial, involving a larger number of patients than Phase II trials.
Typically, the study will compare the treatment with the current standard of care.
Phase IV
These are conducted after a drug has been approved by the Ministry of Health, Labor and Welfare and is on the market, and are called "post-marketing clinical trials."
We will post information about cancer clinical trials being conducted at our hospital.
Not everyone can participate in clinical trials. Each clinical trial has its own conditions, so please inquire with the relevant department.
Clinical Trials and Research Center website also provides information about clinical trials.
Current (publicly available) cancer clinical trials
As of June 1, 2025
| Clinical department | Target diseases and indications | Assignment name |
| Hematology-oncology | acute lymphoblastic leukemia | Amgen sponsored Phase III study of blinatumomab in patients with acute lymphoblastic leukemia |
| Hematology-oncology | acute leukemia | A Phase 1/2 study of DSP-5336 for acute leukemia sponsored by Sumitomo Dainippon Pharma Co., Ltd. |
| Hematology-oncology | B-cell non-Hodgkin lymphoma | A Phase II study of REGN1979 in patients with B-cell non-Hodgkin's lymphoma, sponsored by Parexel International Inc. (in-country clinical trial administrator) |
| Hematology-oncology | Aggressive NK cell leukemia | Phase I/II study of PPMX-T003 for patients with aggressive NK cell leukemia, submitted by Dr. Masahito Onizuka Hematology-oncology |
| Hematology-oncology | Relapsed or refractory B-cell malignancies | The MK-2140-006 basket trial, sponsored by MSD K.K., evaluating MK-2140 as monotherapy and combination therapy in patients with B-cell malignancies |
| Hematology-oncology | Multiple myeloma | Bristol-Myers Squibb-sponsored Phase 3 study comparing iberdomide maintenance therapy with lenalidomide maintenance therapy after autologous stem cell transplant in patients with newly diagnosed multiple myeloma |
| Hematology-oncology | Relapsed or refractory T-cell lymphoma | Bristol-Myers Squibb-Sponsored Phase 1/2 Study of BMS-986369 in Patients with T-Cell Lymphoma |
| Breast Surgery | ER+/HER2- early breast cancer with intermediate-high or high risk of recurrence that has undergone definitive local treatment and is asymptomatic | A Phase III trial of AZD9833 in breast cancer patients sponsored by AstraZeneca K.K. |
| Breast Surgery | Programmed death-ligand (PD-L1)-positive locally recurrent inoperable or metastatic triple-negative breast cancer | A Phase 3, open-label, randomized trial (TROPION-Breast05) sponsored by Daiichi Sankyo Co., Ltd., comparing datopotamab deruxtecan (Dato-DXd) monotherapy or combination with durvalumab with physician's choice of chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) and pembrolizumab in patients with locally recurrent, inoperable, or metastatic triple-negative breast cancer who are programmed death-ligand (PD-L1) positive. |
| Breast Surgery | Untreated triple-negative or hormone receptor low/HER2-negative breast cancer | A Phase III study sponsored by Daiichi Sankyo Co., Ltd. of Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in patients with previously untreated triple-negative or hormone receptor low/HER2-negative breast cancer. |
| Pediatrics | Newly diagnosed intermediate-risk acute lymphoblastic leukemia | pediatrics Shohei Yamamoto, A randomized, open-label, phase 2, two-arm study comparing the efficacy and safety of standard intensive therapy with intensive therapy that adds prinatumomab in subjects aged 0 to 24 years with newly diagnosed intermediate-risk acute lymphoblastic leukemia. |
| Hematology-oncology | Large B-cell lymphoma | Bristol-Myers Squibb-Sponsored Phase 3 Study of BMS-986369 in Patients with Untreated High-Risk Large B-Cell Lymphoma |
| Hematology-oncology | Untreated multiple myeloma patients who are not suitable for autologous stem cell transplantation or who are not planning to undergo autologous stem cell transplantation as their initial treatment | A phase 3 randomized study sponsored by Janssen Pharmaceuticals K.K. comparing the combination of teclistamab, subcutaneous daratumumab, and lenalidomide (Tec-DR) and the combination of talquetamab, subcutaneous daratumumab, and lenalidomide (Tal-DR) with the combination of subcutaneous daratumumab, lenalidomide, and dexamethasone (DRd) in treatment-naïve patients with multiple myeloma who are ineligible for or not planning to undergo autologous stem cell transplantation as initial therapy. |
| Otolaryngology, Head and Neck Surgery | Unresected locally advanced head and neck squamous cell carcinoma | A Phase III trial of GSK4057190A (Dostarlimab) in patients with unresected locally advanced head and neck squamous cell carcinoma, sponsored by GlaxoSmithKline K.K. |
| Breast Surgery | Patients with advanced breast cancer who have BRCA1, BRCA2, or PALB2 mutations and are HR positive, HER2 negative (IHC 0, 1+, 2+/ISH negative) | A Phase III study of saruparib (AZD5305) plus camizestrant in patients with HR-positive, HER2-negative advanced breast cancer sponsored by AstraZeneca K.K. |
| Hematology-oncology | Diffuse large B-cell lymphoma | AbbVie Japan sponsored Phase 3 trial of ABBV-GMAB-3013 (epcolitamab) in patients with diffuse large B-cell lymphoma |
| Hematology-oncology | Untreated chronic lymphocytic leukemia | (In-country clinical trial administrator) A Phase III study of sonrotoclax (BGB-11417) and zanubrutinib (BGB-3111) in patients with untreated chronic lymphocytic leukemia, sponsored by IQVIA Services Japan, LLC. |
| Breast Surgery | HER2-positive metastatic breast cancer | A randomized, open-label, multicenter, phase III study sponsored by Shin Nippon Biosciences PPD (Japan Clinical Trial Manager) to compare the efficacy and safety of zanidatamab or trastuzumab in combination with physician-selected chemotherapy in patients with HER2-positive metastatic breast cancer. |
| Breast Surgery | HR+/HER2- unresectable locally advanced or metastatic breast cancer | A Phase III study of MK-2870 as a single agent or in combination with pembrolizumab in HR+/HER2- metastatic breast cancer sponsored by MSD K.K. |
| Breast Surgery | Triple-negative breast cancer that has not achieved a pathological complete response | A Phase 3 study sponsored by MSD K.K. comparing MK-2870 plus pembrolizumab with investigator's choice of treatment in patients with triple-negative breast cancer who have not achieved a pathological complete response |
| Hematology-oncology | Diffuse large B-cell lymphoma | A phase III study sponsored by MSD K.K. comparing MK-2140 + R-CHOP with R-CHOP for first-line treatment of diffuse large B-cell lymphoma |
| Breast Surgery | Locally advanced (unresectable) or metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer | Phase Ib/III trial sponsored by AstraZeneca K.K. |
| Respiratory Medicine | non-small cell lung cancer | A phase 3 clinical trial sponsored by Kaiwa Pharmaceutical Co., Ltd. comparing gumalontinib and docetaxel in patients with MET-overexpressing non-small cell lung cancer. |
| Obstetrics and Gynecology | Adult patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with high FRα expression | A Phase III study of mirvetuximab soravtansine sponsored by Takeda Pharmaceutical Company Limited in adult patients with recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer with high FRα expression |
| Breast Surgery | Unresectable or metastatic triple-negative breast cancer (PD-L1 CPS less than 10) | A Phase 3 study sponsored by MSD K.K. comparing MK-2870 (sac-TMT) monotherapy and combination therapy with MK-3475 (pembrolizumab) with investigator's choice of treatment as first-line treatment for unresectable or metastatic triple-negative breast cancer (PD-L1 CPS < 10). |
| Hematology-oncology | Chronic lymphocytic leukemia/small lymphocytic lymphoma or non-Hodgkin's lymphoma | (In-country clinical trial manager) Phase I/II study of pirtopultinib for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or non-Hodgkin's lymphoma, at the request of Eli Lilly Japan K.K. |