Colorectal Cancer MetastaticPhase 2NCT05584137
Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC
A Phase 2 study testing HLX26 and HLX10 in people with Colorectal Cancer Metastatic, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- HLX26 and HLX10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2023to 31 Dec 2023
- Phase
- Phase 2
- 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
- Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
- Has at least one measurable lesion per RECIST 1.1 as assessed by investigator.
- Has been treated with 3 prior lines of therapy for the disease and radiographically progressed on or after or could not tolerate prior therapies which include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (if KRAS wild-type), regorafenib, TAS-102, fruquintinib, and BRAF inhibitor (if BRAF mutant-type).
- Submits an archival (≤ 5 years) or newly obtained tumor tissue sample that has not been previously irradiated for the determination of PD-L1 level and mismatch repair (MMR) status to meet the study requirements.
- Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 7 days prior to first dose of study intervention.
- Has a life expectancy of at least 3 months, based on the investigator assessment.
- Has adequate organ function.
Who cannot join
- Has previously been found to have deficient MMR/microsatellite instability-high (dMMR/MSI-H) tumor status.
- The adverse reactions (except alopecia and other adverse reactions determined by the investigator to have no safety risk) of previous anti-tumor therapy have not yet recovered to ≤ grade 1 (CTCAE V5.0).
- Those who are known to have severe anaphylaxis (grade 4 or greater per CTCAE V5.0) to macromolecular protein preparations/monoclonal antibodies or to any component of the investigational product.
- Patients with any of the following unstable or poorly controlled diseases:1)Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;2)Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (a) NYHA Class II or greater cardiac failure or left ventricular ejection fraction (LVEF) < 50%; (b) unstable angina pectoris; (c) myocardial infarction and cerebral infarction within 6 months; (d) clinically significant supraventricular or ventricular arrhythmia that has not been intervened or is poorly controlled after clinical intervention; 3)Other chronic diseases which, in the opinion of the investigator, may compromise the safety of the patient or the integrity of the study.
- Assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced.
- Previous grade 2 or greater immune pneumonia in immunotherapy; previous grade 3 or greater irAEs in immunotherapy.
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- Has had other malignant tumors within 5 years before enrollment, except: (a) those with cured cervical carcinoma in situ or non-melanoma skin cancer; (b) those with cured second primary cancer without recurrence within 5 years; (c) those with double primary cancers believed to be able to benefit from this study; (d) those whose metastasis has been clearly excluded from a certain primary tumor source.
- History of prior treatment with anti-PD-1/L1, anti-CTLA-4, anti-Lag-3 antibodies or any agent targeting T cells.
- Has active autoimmune diseases (including but not limited to the following diseases or syndromes, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism), except: vitiligo or cured childhood asthma/allergy that does not need any intervention in adulthood, autoimmune mediated hypothyroidism treated with stable dose of thyroid replacement hormone, and type I diabetes treated with stable dose of insulin; those in a stable condition and requiring no systemic immunosuppressant therapy (including corticosteroid hormone) are allowed to be enrolled.
- Has received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 14 days before the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short term use of corticosteroids for prophylaxis, such as contrast agents.
- Patients in pregnancy [confirmed by serum beta-human chorionic gonadotropin (ß-HCG) test] or breastfeeding.
- Has a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation.
- Patients with active HBV or HCV infection (HBV DNA ≥ 10*4 copies/mL or positive HCV RNA, but patients with HBV DNA < 10*4 copies / mL after treatment can be included); Subjects with co-infection of hepatitis B and hepatitis C (HBsAg or HBcAb positive, and HCV antibody positive).
- Has received live vaccines within 28 days prior to the first administration.
- Patients whose medical history or any other evidence suggests that participation in the study may confuse the results, or subjects for whom the investigator believes the study is not in their best interest.
- Participating in other clinical studies or less than 28 days from the end of the treatment of the previous clinical study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) in Combination with Serplulimab in Patients with MCRC That Have Received 3 Prior Lines of Therapy
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
Read the detailed description
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
The study is composed of the first stage (escalation stage) and the second stage (expansion stage). In the first stage (escalation stage), a 3 + 3 dose escalation design will be used. Patients will receive 3 dose levels of HLX26 (500mg, 800mg, 1600mg) combined with HLX10 300mg intravenously every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. In the second stage, the safety and efficacy of 2 dose levels of HLX26 (800mg and 1600mg) combined with HLX10 300mg will be evaluated. Eligible subjects will be enrolled in the HLX26 800mg group and HLX26 1600mg group in sequence, 20 subjects per group.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- HLX26, HLX10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX26Drug
Also called Anti-LAG-3 Monoclonal Antibody
Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody
HLX10Drug
Also called Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB
Humanized Anti-Programmed Death-1 Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose cohort 1 of the first stage (escalation stage) | Experimental | In this cohort, HLX26 500 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first).
Interventions:
Drug: HLX26 Drug: HLX10 Receives: Drug: HLX26; Drug: HLX10 |
| Dose cohort 2 of the first stage (escalation stage) | Experimental | In this cohort, HLX26 800 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first).
Interventions:
Drug: HLX26 Drug: HLX10 Receives: Drug: HLX26; Drug: HLX10 |
| Dose cohort 3 of the first stage (escalation stage) | Experimental | In this cohort, HLX26 1600 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first).
Interventions:
Drug: HLX26 Drug: HLX10 Receives: Drug: HLX26; Drug: HLX10 |
| Dose cohort 1 of the second stage (expansion stage) | Experimental | In this cohort, HLX26 800 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 20 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first).
Interventions:
Drug: HLX26 Drug: HLX10 Receives: Drug: HLX26; Drug: HLX10 |
| Dose cohort 2 of the second stage (expansion stage) | Experimental | In this cohort, HLX26 1600 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 20 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first).
Interventions:
Drug: HLX26 Drug: HLX10 Receives: Drug: HLX26; Drug: HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) (the first stage)
The DLT of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Measured: from day1 to day 21
Maximum Tolerated Dose (MTD) (the first stage)
The MTD of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Measured: from day1 to day 21
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by Investigator (the second stage)
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigator.
Measured: approximately up to 6 months
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from first dose to death due to any cause.
Measured: approximately up to 24 months
Progression-Free Survival (PFS) per RECIST 1.1 assessed by Investigator
PFS is defined as the time from first dose to the first documented disease progression per RECIST 1.1 by investigator or death due to any cause, whichever occurs first.
Measured: approximately up to 24 months
Duration of Response (DOR) per RECIST 1.1 assessed by Investigator
DOR is defined as the time from the first documented CR or PR until disease progression or death due to any cause, whichever occurs first. DOR is only for participants who demonstrate confirmed ORR.
Measured: approximately up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start15 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Due to poor clinical trial accrual, the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584137
- Sponsor's protocol ID
- HLX26HLX10-mCRC201
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) in Combination with Serplulimab in Patients with MCRC That Have Received 3 Prior Lines of Therapy
- ClinicalTrials.gov ID
- NCT05584137
- Acronym / sponsor ID
- HLX26HLX10-mCRC201
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor clinical trial accrual, the study was terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Oct 2022 (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.
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
Detailed description
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
The study is composed of the first stage (escalation stage) and the second stage (expansion stage). In the first stage (escalation stage), a 3 + 3 dose escalation design will be used. Patients will receive 3 dose levels of HLX26 (500mg, 800mg, 1600mg) combined with HLX10 300mg intravenously every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. In the second stage, the safety and efficacy of 2 dose levels of HLX26 (800mg and 1600mg) combined with HLX10 300mg will be evaluated. Eligible subjects will be enrolled in the HLX26 800mg group and HLX26 1600mg group in sequence, 20 subjects per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose cohort 1 of the first stage (escalation stage) | Experimental | Drug: HLX26, Drug: HLX10In this cohort, HLX26 500 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). Interventions: Drug: HLX26 Drug: HLX10 |
| Dose cohort 2 of the first stage (escalation stage) | Experimental | Drug: HLX26, Drug: HLX10In this cohort, HLX26 800 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). Interventions: Drug: HLX26 Drug: HLX10 |
| Dose cohort 3 of the first stage (escalation stage) | Experimental | Drug: HLX26, Drug: HLX10In this cohort, HLX26 1600 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 3 to 6 subjects will be enrolled in this cohort. 3 to 6 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). Interventions: Drug: HLX26 Drug: HLX10 |
| Dose cohort 1 of the second stage (expansion stage) | Experimental | Drug: HLX26, Drug: HLX10In this cohort, HLX26 800 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 20 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). Interventions: Drug: HLX26 Drug: HLX10 |
| Dose cohort 2 of the second stage (expansion stage) | Experimental | Drug: HLX26, Drug: HLX10In this cohort, HLX26 1600 mg in combination with HLX10 300 mg will be intravenously administered every 3 weeks. 20 subjects will be enrolled in this cohort. Patients will be treated with investigational products until 2 years, disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). Interventions: Drug: HLX26 Drug: HLX10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
- Has at least one measurable lesion per RECIST 1.1 as assessed by investigator.
- Has been treated with 3 prior lines of therapy for the disease and radiographically progressed on or after or could not tolerate prior therapies which include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (if KRAS wild-type), regorafenib, TAS-102, fruquintinib, and BRAF inhibitor (if BRAF mutant-type).
- Submits an archival (≤ 5 years) or newly obtained tumor tissue sample that has not been previously irradiated for the determination of PD-L1 level and mismatch repair (MMR) status to meet the study requirements.
- Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 7 days prior to first dose of study intervention.
Key exclusion criteria (16 listed)
- Has previously been found to have deficient MMR/microsatellite instability-high (dMMR/MSI-H) tumor status.
- The adverse reactions (except alopecia and other adverse reactions determined by the investigator to have no safety risk) of previous anti-tumor therapy have not yet recovered to ≤ grade 1 (CTCAE V5.0).
- Those who are known to have severe anaphylaxis (grade 4 or greater per CTCAE V5.0) to macromolecular protein preparations/monoclonal antibodies or to any component of the investigational product.
- Patients with any of the following unstable or poorly controlled diseases:1)Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;2)Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (a) NYHA Class II or greater cardiac failure or left ventricular ejection fraction (LVEF) < 50%; (b) unstable angina pectoris; (c) myocardial infarction and cerebral infarction within 6 months; (d) clinically significant supraventricular or ventricular arrhythmia that has not been intervened or is poorly controlled after clinical intervention; 3)Other chronic diseases which, in the opinion of the investigator, may compromise the safety of the patient or the integrity of the study.
- Assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced.
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 |
|---|---|---|
| HLX26Also: Anti-LAG-3 Monoclonal AntibodyHumanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody | Drug | Dose cohort 1 of the first stage (escalation stage), Dose cohort 1 of the second stage (expansion stage), Dose cohort 2 of the first stage (escalation stage), Dose cohort 2 of the second stage (expansion stage), Dose cohort 3 of the first stage (escalation stage) |
| HLX10Also: Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMABHumanized Anti-Programmed Death-1 Monoclonal Antibody | Drug | Dose cohort 1 of the first stage (escalation stage), Dose cohort 1 of the second stage (expansion stage), Dose cohort 2 of the first stage (escalation stage), Dose cohort 2 of the second stage (expansion stage), Dose cohort 3 of the first stage (escalation stage) |
Primary outcome
Dose-limiting toxicity (DLT) (the first stage)
Time frame: from day1 to day 21
The DLT of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Maximum Tolerated Dose (MTD) (the first stage)
Time frame: from day1 to day 21
The MTD of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by Investigator (the second stage)
Time frame: approximately up to 6 months
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigator.
3 secondary outcomes
Overall Survival (OS)
Time frame: approximately up to 24 months
Progression-Free Survival (PFS) per RECIST 1.1 assessed by Investigator
Time frame: approximately up to 24 months
Duration of Response (DOR) per RECIST 1.1 assessed by Investigator
Time frame: approximately up to 6 months
Results and safety
The study was stopped early (reason given: Due to poor clinical trial accrual, the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX26 and HLX10 in people with Colorectal Cancer Metastatic, run by Shanghai Henlius Biotech at 2 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 7 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Due to poor clinical trial accrual, the study was terminated.). Results are not available in the source record.
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?
Dose-limiting toxicity (DLT) (the first stage) (time frame: from day1 to day 21). 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 15 Oct 2024.