HER2-positive Breast CancerPhase 1NCT04450732
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
A Phase 1 study testing GQ1001 in people with HER2-positive Breast Cancer and HER2-positive Biliary Tract Cancer, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 24 sites in 3 countries.
Trial summary
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas
- What is being tested?
- GQ1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 7 Jul 2020to 1 May 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form and able to comply with the protocol;
- Male and female subjects ≥18 years of age;
- ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
- LVEF ≥ 50% as determined by echocardiography (ECHO);
- Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.
- Definition of HER2-positive
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- Advanced/unresectable or metastatic breast cancer: immunohistochemistry (IHC) 3+, or IHC 2+ and in situ hybridization positive (ISH+)*;
- Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: IHC 3+, or IHC 2+ and ISH+*;
- Other HER2-positive advanced/unresectable or metastatic solid malignant tumor: determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques as appropriate;
- ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. ISH assay is not required when IHC result is 3+. ISH assay should be performed to confirm HER2 positivity when IHC result is 2+.
- Adequate organ function confirmed at screening and within 7 days before the first treatment, as evidenced by:
- Platelet count: ≥ 100,000/mm3 ; Hemoglobin : ≥ 9 g/dL; Absolute neutrophil count (ANC): ≥ 1500/mm3 ; Serum creatinine: ≤ 1.5 × ULN (upper limit of normal), or creatinine clearance ≥ 60 mL/min (using Cockcroft Gault formula) ; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) : ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present); Total bilirubin : ≤ 1.5 × ULN (except for patients with Gilbert's Syndrome); Prothrombin time and activated partial thromboplastin time: ≤ 1.5 × ULN.
- Adequate washout period before the first treatment as defined by:
- Major surgery: ≥ 4 weeks. Radiation therapy: ≥ 4 weeks (≥ 2 weeks for palliative stereotactic radiation therapy without abdominal). Autologous transplantation: ≥ 3 months.
- Hormonal therapy: ≥ 2 weeks or per Investigator's discretion for breast cancer patients.
- Chemotherapy or targeted therapy (including antibody drug therapy): ≥ 3 weeks (≥ 2 weeks for 5 flourouracil-based agents, folinate agents, and/or weekly paclitaxel; ≥ 2 weeks (or 5 half-lives, whichever is shorter) for tyrosine kinase inhibitors; ≥ 4 weeks for HER2-directed biologic therapies; ≥ 6 weeks for nitrosoureas or mitomycin C). Immunotherapy: ≥ 4 weeks. Strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor: ≥ 3 elimination half-lives . Any investigational agents or treatments: ≥ 4 weeks.
- Patients without a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infection within the past 12 months may be enrolled per the discretion of the Investigator.
Who cannot join
- Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy;
- Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer);
- Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to:
- Medical history of symptomatic chronic heart failure (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment;
- Medical history of myocardial infarction or unstable angina within 6 months of the first treatment;
- Corrected QT interval by Fridericia (QTcF) prolongation of > 450 milliseconds (ms) in males and > 470 ms in females;
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- Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen;
- Known hypersensitivity to either the drug substances or inactive ingredients in the drug product;
- Existing Grade ≥ 2 peripheral neuropathy;
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator;
- Cumulative anthracycline dose > 360 mg/m2 doxorubicin or equivalent;
- Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;
- Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus [HCV]) or hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive) except subjects with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated;
- Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the Investigator, might confound the results of the trial, interfere with the patient's participation and compliance;
- Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment;
- Male and female subjects who are unwilling to use adequate contraceptive methods (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) during the study and for at least 7 months after the last dose of GQ1001.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
China21 sites, 21 recruiting
- Recruiting
Beijing Tongren Hospital Affiliated to Capital University of Medical Sciences
Beijing, Beijing Municipality, 100005
Shurong Zhang
- Recruiting
Chinese PLA general hospital
Beijing, Beijing Municipality, 100039
Bo Yang
- Recruiting
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui, 233099
Huan Zhou
Dianming Li
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410029
Shanzhi Gu
- Recruiting
West China School of Medicine and West China Hospital, Sichuan University
Chengdu, Sichuan, 610044
Lei Liu
- Recruiting
Southern Medical University Hospital in the south
Guangzhou, Guangdong, 516006
Yabing Guo
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 528406
Jieqiong Liu
- Recruiting
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Lulu Liu
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Meiyu Fang
- Recruiting
Shandong Tumor Hospital
Jinan, Shandong, 250117
Zhehai Wang
Yuping Sun
- Recruiting
Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Wei Guo
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jia Fan
Huichuan Sun
- Recruiting
Ruijin Hospital, Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200120
Jun Zhang
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li
Ye Guo
- Recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
Xianbao Zhan
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Zhendong Li
- Recruiting
Hubei Huazhong University of Science and provincial Cancer Hospital Affiliated Union Hospital of Tongji Medical College
Wuhan, Hubei, 430022
Kunyu Yang
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Dongde Wu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yanqiu Zhao
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Hong Zong
Australia2 sites, 1 recruiting
- Completed
Cabrini Institute in Melbourne, Australia
Melbourne, Victoria, 3050
- Recruiting
Scientia Clinical Research Limited
Randwick, New South Wales, 2031
1800 727 874
Charlotte Lemech, MD
United States1 site
- Completed
M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Being tested
- GQ1001
- Keywords
- HER2-positive, Biliary Tract Cancer, Salivary Gland Carcinomas, Non- Small Cell Lung Cancer, Advanced Solid Tumor
- Medical subject headings
- Biliary Tract Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GQ1001Drug
anti-HER2 antibody drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design. Receives: Drug: GQ1001 |
| Dose Expansion | Experimental | GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts. Receives: Drug: GQ1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs).
Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.
Measured: End of Cycle 1 (21-day cycle)
Maximum Tolerated Dose (MTD) or Dose Recommended for Dose Expansion (DRDE)
The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.
Measured: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable
Secondary outcomes (14)
Incidence and Severity of Adverse Events (AEs)
Safety and Tolerability of GQ1001
Measured: from baseline to 30 days after last dose
Number of Participants with Abnormal Laboratory Values
Safety and Tolerability of GQ1001
Measured: rom baseline through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuationafter last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001
Measured: through study completion, an average of 1 year
Peak Plasma Concentration of GQ1001 (Cmax)
Measured: through study completion, an average of 1 year
Time at which the Cmax is Observed (Tmax)
Measured: through study completion, an average of 1 year
Half Life of GQ1001 (T1/2)
Measured: through study completion, an average of 1 year
Mean Residence Time of GQ1001 (MRT)
Measured: through study completion, an average of 1 year
Volume of Distribution of GQ1001 (Vd)
Measured: through study completion, an average of 1 year
Preliminary Efficacy of GQ1001 Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and CT of MRI scans
Measured: through study completion, an average of 1 year
Immunogenicity
Anti-GQ1001 antibody/anti-therapeutic antibody
Measured: through study completion, an average of 1 year
Preliminary Efficacy
objective response rate (ORR)
Measured: through study completion, an average of 1 year
Preliminary Efficacy
disease control rate (DCR)
Measured: through study completion, an average of 1 year
Preliminary Efficacy
duration of response (DoR)
Measured: through study completion, an average of 1 year
Preliminary Efficacy
progression-free survival (PFS)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start7 Jul 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive Breast CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Modified 3+3 Design
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450732
- Sponsor's protocol ID
- GQ1001X2101
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhou C, Wang B, Teng C, Yang H, Piha-Paul SA, Richardson G, Malalasekera A, Sun Y, Wang W, Liu J, Shi Y, Zhan X, Lemech C. A phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001 in patients with previously treated HER2 positive advanced solid tumors. J Transl Med. 2025 Jan 9;23(1):37. doi: 10.1186/s12967-024-05985-z.
PubMed 39789619
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04450732
- Acronym / sponsor ID
- GQ1001X2101
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Keywords
- HER2-positive, Biliary Tract Cancer, Salivary Gland Carcinomas, Non- Small Cell Lung Cancer, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 29 Jun 2020 (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.
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Modified 3+3 Design
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: GQ1001GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design. |
| Dose Expansion | Experimental | Drug: GQ1001GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed informed consent form and able to comply with the protocol;
- Male and female subjects ≥18 years of age;
- ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
- LVEF ≥ 50% as determined by echocardiography (ECHO);
- Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.
Key exclusion criteria (16 listed)
- Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy;
- Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer);
- Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to:
- Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen;
- Known hypersensitivity to either the drug substances or inactive ingredients in the drug product;
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 |
|---|---|---|
| GQ1001anti-HER2 antibody drug conjugate | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Dose Limiting Toxicities (DLTs).
Time frame: End of Cycle 1 (21-day cycle)
Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.
Maximum Tolerated Dose (MTD) or Dose Recommended for Dose Expansion (DRDE)
Time frame: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable
The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.
14 secondary outcomes
Incidence and Severity of Adverse Events (AEs)
Time frame: from baseline to 30 days after last dose
Number of Participants with Abnormal Laboratory Values
Time frame: rom baseline through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuationafter last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001
Time frame: through study completion, an average of 1 year
Peak Plasma Concentration of GQ1001 (Cmax)
Time frame: through study completion, an average of 1 year
Time at which the Cmax is Observed (Tmax)
Time frame: through study completion, an average of 1 year
Half Life of GQ1001 (T1/2)
Time frame: through study completion, an average of 1 year
Mean Residence Time of GQ1001 (MRT)
Time frame: through study completion, an average of 1 year
Volume of Distribution of GQ1001 (Vd)
Time frame: through study completion, an average of 1 year
Preliminary Efficacy of GQ1001 Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and CT of MRI scans
Time frame: through study completion, an average of 1 year
Immunogenicity
Time frame: through study completion, an average of 1 year
Preliminary Efficacy
Time frame: through study completion, an average of 1 year
Preliminary Efficacy
Time frame: through study completion, an average of 1 year
Preliminary Efficacy
Time frame: through study completion, an average of 1 year
Preliminary Efficacy
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 39789619Zhou C, Wang B, Teng C, Yang H, Piha-Paul SA, Richardson G, Malalasekera A, Sun Y, Wang W, Liu J, Shi Y, Zhan X, Lemech C. A phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001 in patients with previously treated HER2 positive advanced solid tumors. J Transl Med. 2025 Jan 9;23(1):37. doi: 10.1186/s12967-024-05985-z.
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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. This study is not recruiting at the moment.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GQ1001 in people with HER2-positive Breast Cancer and HER2-positive Biliary Tract Cancer, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 24 sites in 3 countries.
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 17 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China, Australia, United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Shi (0512-66526166, shiy@genequantum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs). (time frame: End of Cycle 1 (21-day cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450732, which also lists 1 linked publication.
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 5 Dec 2023.