Relapsed/Refractory Multiple MyelomaPhase 3NCT06508983
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
A Phase 3 study testing SG301 Injection, pomalidomide and dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Hangzhou Sumgen Biotech Co., Ltd. at 12 sites in China.
Trial summary
The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- SG301 Injection, pomalidomide and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 12 sitesChina
- Study dates
- 14 Jun 2024to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form (ICF).
- Males and females aged 18-75 years (inclusive)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
- Expected survival time of ≥3 months.
- Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
- Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
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- Subjects must have documented evidence of PD on or after the last regimen.
- Adequate function of vital organs
- Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.
Who cannot join
- Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
- Bone independent extramedullary disease at screening.
- Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
- Previous exposure to pomalidomide.
- Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
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- Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;
- Active hepatitis B, or C.
- Known HIV infection.
- Known active tuberculosis or positive treponema pallidum antibodies.
- Subjects with clinical significant organ dysfunction that does not meet the study needs.
- Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
- Known allergy to any component of the investigational medicinal product.
- Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100024
Wenming Chen, Doctor
Ying Tian
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000
Shunqing Wang
Wei Zhou
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhongjun Xia
Xiaoqin Chen
- Recruiting
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310056
Wenbin Qian
Xuzhao Zhang
- Recruiting
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Haiping Yang
Bingke Zhu
- Recruiting
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006
ZhengZheng Fu
Yingying Zhai
- Recruiting
Shanxi Provincial Hospital
Taiyuan, Shanxi, 030000
Liping Su
Jingrong Wang
- Recruiting
Tianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, 300060
Yafei Wang
Zhiying Zhang
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yafei Wang
Haifeng Zhao
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Chunyan Sun
Fei Zhao
- Recruiting
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710000
Wanhong Zhao
Fangxia Wang
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baijun Fang
Yuzhang Liu
About this study
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression.
This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- SG301 Injection, SG301 placebo, pomalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG301 InjectionDrug
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
SG301 placeboDrug
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
pomalidomideDrug
Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
dexamethasoneDrug
Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI < 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| SG301 Injection in combination with pomalidomide and dexamethasone | Experimental | Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. Receives: Drug: SG301 Injection; Drug: pomalidomide; Drug: dexamethasone |
| Placebo in combination with pomalidomide and dexamethasone | Placebo comparator | Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. Receives: Drug: SG301 placebo; Drug: pomalidomide; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events （stage 1）
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
Measured: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Recommended stage 2 dose of SG301 (Stage 1)
Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data
Measured: Up to approximately 6 months.
Progression Free Survival (Stage 2)
Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).
Measured: From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
Secondary outcomes (9)
Pharmacokinetics (PK): AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Measured: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK): Cmax
Cmax to maximum drug concentration.
Measured: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK):limination half-life (T1/2)
Limination half-life (T1/2) of the drug after administration.
Measured: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Immunogenicity endpoints
Anti-SG301 antibody, neutralizing antibody (to be detected only in case of the presence of anti-SG301 antibody.
Measured: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Overall Response Rate
ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response
Measured: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate)
≥VGPR Rate (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), and very good partial response (VGPR) as best overall response.
Measured: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.
Duration of Response
Duration of response will be restricted to subjects who achieve a best objective response of PR or better.
Measured: From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.
Overall Survival
Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
Measured: From baseline through the end of study, assessed up to approximately 4 years.
Percentage of Participants With Minimal Residual Disease (MRD)
MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR or sCR, to determine the depth of response at the molecular level.
Measured: From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start14 Jun 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This Study consists of Stage 1 and Stage 2. Stage 1 ：Single group. Subjects will receive SG301 Injection in combination with pomalidomide and dexamethasone. Stage 2：Parallel. Subjects will be randomized to receive SG301 Injection in combination with pomalidomide and dexamethasone or placebo in combination with pomalidomide and dexamethasone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508983
- Sponsor's protocol ID
- CSG-301-301
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06508983
- Acronym / sponsor ID
- CSG-301-301
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Jul 2024 (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 evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.
Detailed description
This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression.
This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This Study consists of Stage 1 and Stage 2. Stage 1 ：Single group. Subjects will receive SG301 Injection in combination with pomalidomide and dexamethasone. Stage 2：Parallel. Subjects will be randomized to receive SG301 Injection in combination with pomalidomide and dexamethasone or placebo in combination with pomalidomide and dexamethasone.
| Arm | Type | Receives |
|---|---|---|
| SG301 Injection in combination with pomalidomide and dexamethasone | Experimental | Drug: SG301 Injection, Drug: pomalidomide, Drug: dexamethasoneParticipants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. |
| Placebo in combination with pomalidomide and dexamethasone | Placebo comparator | Drug: SG301 placebo, Drug: pomalidomide, Drug: dexamethasoneParticipants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand and voluntarily sign the informed consent form (ICF).
- Males and females aged 18-75 years (inclusive)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
- Expected survival time of ≥3 months.
- Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
Key exclusion criteria (14 listed)
- Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
- Bone independent extramedullary disease at screening.
- Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
- Previous exposure to pomalidomide.
- Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
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 |
|---|---|---|
| SG301 InjectionDosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter. | Drug | SG301 Injection in combination with pomalidomide and dexamethasone |
| SG301 placeboDosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter. | Drug | Placebo in combination with pomalidomide and dexamethasone |
| pomalidomideDosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle. | Drug | Placebo in combination with pomalidomide and dexamethasone, SG301 Injection in combination with pomalidomide and dexamethasone |
| dexamethasoneDosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI < 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle. | Drug | Placebo in combination with pomalidomide and dexamethasone, SG301 Injection in combination with pomalidomide and dexamethasone |
Primary outcome
Adverse events （stage 1）
Time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
Recommended stage 2 dose of SG301 (Stage 1)
Time frame: Up to approximately 6 months.
Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data
Progression Free Survival (Stage 2)
Time frame: From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).
9 secondary outcomes
Pharmacokinetics (PK): AUC
Time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK): Cmax
Time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK):limination half-life (T1/2)
Time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Immunogenicity endpoints
Time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Overall Response Rate
Time frame: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate)
Time frame: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.
Duration of Response
Time frame: From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.
Overall Survival
Time frame: From baseline through the end of study, assessed up to approximately 4 years.
Percentage of Participants With Minimal Residual Disease (MRD)
Time frame: From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SG301 Injection, pomalidomide and dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Hangzhou Sumgen Biotech Co., Ltd. at 12 sites in China.
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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Yang (+86 010-56315401, yangjing@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events （stage 1） (time frame: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.). 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 10 Jul 2026.