Prostatic NeoplasmsPhase 1NCT06104449
A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)
A Phase 1 study testing Opevesostat, Dexamethasone and Fludrocortisone acetate in people with Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer, run by Merck Sharp & Dohme LLC at 3 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- Opevesostat, Dexamethasone and Fludrocortisone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesJapan
- Study dates
- 14 Nov 2023to 17 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nmol/L)
- Participants receiving bone anti-resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks prior to the start of study intervention.
- Has progressed on or after treatment with at least 1 line of NHAs in metastatic hormone-sensitive prostate cancer (mHSPC) or in castration-resistant prostate cancer (CRPC) for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane-based chemotherapy in mHSPC or in CRPC, or ineligibility for chemotherapy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to allocation
- If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom.
Who cannot join
- Has a history of pituitary dysfunction
- Has brain metastases
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Has an active or uncontrolled autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- Has an active infection or other medical condition that would make corticosteroid contraindicated
- Has serious persistent infection within 2 weeks prior to the start of the study intervention
Show all 25Show fewer
- Participants on an unstable dose of thyroid hormone therapy within 6 months prior to the start of the study intervention
- Has poorly controlled diabetes mellitus
- Hypotension: systolic blood pressure (BP) < 110 mmHg, or uncontrolled hypertension: systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg, in 2 out of 3 recordings with optimized antihypertensive therapy
- Has active or unstable cardio/cerebro-vascular disease, including thromboembolic event
- Is unable to swallow orally administered medication or known gastrointestinal (GI) disease or GI procedure that may interfere with absorption of study intervention
- Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to the start of the study intervention and not adequately recovered from the toxicities and/or complications
- Has received aldosterone antagonist (e.g. spironolactone, eplerenone) and phenytoin within 4 weeks prior to the start of the study intervention
- Has received radiotherapy within 4 weeks prior to the start of the study intervention, or radiation related toxicities, requiring corticosteroids
- Has received chemotherapy within the last 4 weeks (2 weeks for oral or weekly chemotherapy; 6 weeks for nitrosoureas and mitomycin C) prior to the start of the study intervention
- Has received prior enzalutamide and apalutamide within 3 weeks, or abiraterone and darolutamide within 2 weeks prior to the start of the study intervention
- Systemic use of the following medications within 2 weeks prior to the start of study intervention: strong cytochrome P450 (CYP)3A4 inducers: e.g., carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) and strong CYP3A4 inhibitors: e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, grapefruit juice
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) within 4 weeks prior to the start of the study intervention
- Has received treatment with 5-α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to the start of the study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- History of human immunodeficiency virus (HIV) infection
- Has a history of Hepatitis B or active Hepatitis C virus
- Has a "superscan" bone scan
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the start of the study intervention
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
National Cancer Center Hospital East ( Site 0001)
Kashiwa, Chiba, 277-8577
Toho University Sakura Medical Center ( Site 0003)
Sakura, Chiba, 285-8741
Yokohama City University Medical Center ( Site 0002)
Yokohama, Kanagawa, 232-0024
About this study
Official title: A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy.
Read the detailed description
After approval of Protocol amendment 03, participants in the survival follow-up phase will have a final survival contact and then be discontinued from the study.
- Being tested
- Opevesostat, Dexamethasone, Fludrocortisone acetate, Hydrocortisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpevesostatDrug
Also called MK-5684
Tablets to be taken orally.
DexamethasoneDrug
Also called Decadron
Tablets to be taken orally.
Fludrocortisone acetateDrug
Tablet to be taken orally.
HydrocortisoneDrug
Tablets to be taken orally as a recue medication.
| Study group | Role | What they receive |
|---|---|---|
| Opevesostat | Experimental | Participants receive opevesostat 5 mg by oral tablets twice daily plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily continuously until progression. Hydrocortisone up to 100 mg oral dose will also be provided to participants for use as rescue medication. Receives: Drug: Opevesostat; Drug: Dexamethasone; Drug: Fludrocortisone acetate; Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 by the Investigator
The following events, if considered drug related by the Investigator, will be considered a DLT: Grade 4 hematologic toxicity lasting ≥7 days, except anemia and thrombocytopenia; Grade 3 nausea, vomiting, diarrhea or fatigue lasting >3 days despite optimal supportive care; other nonhematologic grade ≥3 toxicities of any duration (not laboratory); Grade ≥3 nonhematologic laboratory abnormality (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; missing >25% of opevesostat doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.
Measured: Up to 28 days
Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Measured: Up to approximately 24 months
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Measured: Up to approximately 24 months
Secondary outcomes (13)
Maximum Plasma Concentration (Cmax) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Time to Maximum Plasma Concentration (Tmax) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Area Under the Curve from Time 0 to 12 hours postdose (AUC0-12) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-12.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Apparent Volume of Distribution (Vz/F) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Vz/F.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Oral Clearance (CL/F) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the CL/F.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Half-Life (t½) of opevesostat
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t½.
Measured: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Prostate-specific Antigen (PSA) response
Percentage of participants in the analysis population who have a reduction in PSA level of ≥50% measured twice ≥3 weeks apart.
Measured: Up to approximately 24 months
Time to Prostate-specific Antigen (PSA) Progression
Time from first dose of study drug to PSA progression. PSA progression date is defined as the date of 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Measured: Up to approximately 24 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time from first dose of study drug to radiographic progression, or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Percentage of participants in the analysis population who have a best overall response of either confirmed Complete Response (CR) or a confirmed Partial Response (PR) per PCWG-modified RECIST 1.1.
Measured: Up to approximately 24 months
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time from first documented evidence of confirmed Complete Response (CR) or Partial Response (PR) per PCWG-modified RECIST 1.1 until disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 24 months
Overall Survival (OS)
Time from first dose of study intervention to death due to any cause.
Measured: Up to approximately 24 months
Blood Concentrations of Steroids
Blood samples collected at multiple timepoints after the administration of opevesostat will be used to determine the blood concentrations of steroids.
Measured: Day 1, Day 8, Day 29, Day 85, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start14 Nov 2023
- Primary completion20 Feb 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104449
- Sponsor's protocol ID
- 5684-005
- Other IDs
- MK-5684-005, jRCT2031230431
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT06104449
- Acronym / sponsor ID
- 5684-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy.
Detailed description
After approval of Protocol amendment 03, participants in the survival follow-up phase will have a final survival contact and then be discontinued from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opevesostat | Experimental | Drug: Opevesostat, Drug: Dexamethasone, Drug: Fludrocortisone acetate, Drug: HydrocortisoneParticipants receive opevesostat 5 mg by oral tablets twice daily plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily continuously until progression. Hydrocortisone up to 100 mg oral dose will also be provided to participants for use as rescue medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nmol/L)
- Participants receiving bone anti-resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks prior to the start of study intervention.
- Has progressed on or after treatment with at least 1 line of NHAs in metastatic hormone-sensitive prostate cancer (mHSPC) or in castration-resistant prostate cancer (CRPC) for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane-based chemotherapy in mHSPC or in CRPC, or ineligibility for chemotherapy
Key exclusion criteria (25 listed)
- Has a history of pituitary dysfunction
- Has brain metastases
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Has an active or uncontrolled autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- Has an active infection or other medical condition that would make corticosteroid contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpevesostatAlso: MK-5684Tablets to be taken orally. | Drug | Opevesostat |
| DexamethasoneAlso: DecadronTablets to be taken orally. | Drug | Opevesostat |
| Fludrocortisone acetateTablet to be taken orally. | Drug | Opevesostat |
| HydrocortisoneTablets to be taken orally as a recue medication. | Drug | Opevesostat |
Primary outcome
Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 by the Investigator
Time frame: Up to 28 days
The following events, if considered drug related by the Investigator, will be considered a DLT: Grade 4 hematologic toxicity lasting ≥7 days, except anemia and thrombocytopenia; Grade 3 nausea, vomiting, diarrhea or fatigue lasting >3 days despite optimal supportive care; other nonhematologic grade ≥3 toxicities of any duration (not laboratory); Grade ≥3 nonhematologic laboratory abnormality (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; missing >25% of opevesostat doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 24 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 24 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
13 secondary outcomes
Maximum Plasma Concentration (Cmax) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Time to Maximum Plasma Concentration (Tmax) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Area Under the Curve from Time 0 to 12 hours postdose (AUC0-12) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Apparent Volume of Distribution (Vz/F) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Oral Clearance (CL/F) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Half-Life (t½) of opevesostat
Time frame: Day 1, Day 8, Day 29, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Prostate-specific Antigen (PSA) response
Time frame: Up to approximately 24 months
Time to Prostate-specific Antigen (PSA) Progression
Time frame: Up to approximately 24 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time frame: Up to approximately 24 months
Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time frame: Up to approximately 24 months
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Blood Concentrations of Steroids
Time frame: Day 1, Day 8, Day 29, Day 85, and at first visit after the last dose of opevesostat (up to approximately 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Opevesostat, Dexamethasone and Fludrocortisone acetate in people with Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer, run by Merck Sharp & Dohme LLC at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 by the Investigator (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.