Malignant Solid TumorPhase 1/2NCT04632108
A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing ASKB589 Injection in people with Malignant Solid Tumor, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- ASKB589 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jan 2021to 31 Dec 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to RECIST 1.1 criteria, all patients must have at least one measurable lesion, and the tumor lesions must be accurately measured in at least one dimension, and lesions previously treated with radiotherapy or local therapy are only evaluated as non-target lesions. Bone metastatic lesions are not considered as measurable lesions;
- ECOG performance status (PS) 0-1;
- The results of the laboratory tests must meet all the following criteria:
- （1）Haemoglobin≥9 g/dL；platelet count≥ 100 × 109/L；absolute neutrophil count≥ 1.5 × 109/L；
- （2）Albumin≥ 3.0g/dL；total bilirubin ≤ 1.5 times the upper limit of normal (ULN)；aspartate transaminase and alanine aminotransferase≤ 2.5 times ULN if no demonstrable liver metastases ( ≤5 times ULN in the presence of liver metastases);
- （3）Creatinine clearance≥ 50ml/min；
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- （4）Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy)
- 4.Life expectancy of at least 3 months;
- 5.Patients who are supposed to be enrolled into the monotherapy dose escalation study must meet all the following criteria:
- Patients of either gender, aged from 18 years old to 70;
- Patients with histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic malignant solid tumor, for whom have no standard therapy or have no access to standard therapy for various reasons.
- 6.Patients who are supposed to be enrolled into the monotherapy dose expansion study must meet all the following criteria:
- Patients of either gender, aged ≥ 18 years old；
- Patients with histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer, for whom have no standard therapy or have no access to standard therapy for various reasons, and that tumor tissue samples are CLDN18.2 positive detected by central laboratory (medium-high expression)；
- Other tumor types with good potential benefits will be included according to the results of the clinical results of same target products (CLDN18.2-positive tumors).
- 7.Patients who are supposed to be enrolled into the dose escalation of ASKB589 combined with chemotherapy should meet all the following criteria:
- Patients of either gender, aged from 18 years old to 70.
- Patients with gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer who are tolerant to CAPOX, GEM+Nab-P chemotherapy.
- Patients with gastric cancer, gastroesophageal junction adenocarcinoma who are intolerant to anti-human epidermal growth factor receptor 2 (anti-HER2) drug therapy.
- Other tumor types with good potential benefits will be included according to the results of mono-therapy dose expansion and the clinical results of same target products.
- 8.Patients who are supposed to be enrolled into the dose expansion of ASKB589 combined with chemotherapy should meet all the following criteria:
- Patients of either gender, aged ≥ 18 years old.
- Patients with gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer who are tolerant to CAPOX, GEM+Nab-P chemotherapy, and that tumor tissue samples are CLDN18.2 positive detected by central laboratory.
- Patients with gastric cancer, gastroesophageal junction adenocarcinoma that who are intolerant to anti-HER2 drug therapy.
- Other tumor types with good potential benefits will be included according to the results of this study and the clinical results of same target products.
Who cannot join
- Patients have a history of severe allergic reactions to monoclonal antibodies or are intolerance to monoclonal antibodies, or those who are allergic to experimental drug and any component of the drug.
- Patients have received a treatment of whole blood or blood component transfusion or various growth factor treatments within 14 days prior to enrollment.
- Patients have received anti-tumor therapy within 14 days prior to enrollment，including but not limited to radiotherapy, chemotherapy, targeted therapy, treatment with herbal medications or other treatments that have known antitumor activity . Patients who have undergone palliative radiotherapy for bone metastases and whose acute toxicity has returned to normal can be selected;
- Patients have received systemic immunosuppressive therapy（such as systemic corticosteroids）within 14 days prior to enrollment. However, patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30mg per day of hydrocortisone or 10mg per day of prednisone) are allowed；patients are allowed to receive a single dose of systemic corticosteroids treatment；
- Patients have participated in other clinical trials within 28 days prior to enrollment; patients who have participated monoclonal antibody clinical trials within 2 months prior to sign written informed consent form also cannot participate in this trial；
- Patients have received major surgical operation within 28 days prior to enrollment or schedule to perform major surgery during the period of this clinical trial;
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- Patients have gastrointestinal diseases such as gastrinoma, duodenitis, gastric ulcer, duodenal ulcer, pancreatitis or upper gastrointestinal hemorrhage, caused by nonmalignant tumor (gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer)withinwithin 3 months prior to enrollment；Patients have gastric inlet and outlet obstruction or suspected obstruction within 1 months prior to enrollment；
- Known to have irritable bowel syndrome, ulcerative colitis, Crohn's disease, gastric outlet obstruction, etc., or any other causes that can cause long-term chronic nausea,persistent repeated vomiting or diarrhea, and uncontrolled or severe gastrointestinal bleeding;
- Have a history of diagnosed neurological or mental disorders, including epilepsy or dementia;
- Patients with any other malignant tumors within the past 5 years, cured cervical carcinoma in situ, basal cell, or squamous cell skin cancer are not included;
- Known active central nervous system (CNS) metastasis or suspected cancerous meningitis;
- Uncontrollable third-space effusion in clinical practice, which is deemed unsuitable for enrollment by the researchers;
- Patients currently suffering from diseases that affect intravenous injection and venous blood sampling;
- Patients suffering from major cardiovascular diseases, including:
- （1）Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months before the first drug treatment；
- （2）History of clinically significant ventricular arrhythmia (such as sustained ventricular tachycardia, ventricular fibrillation or torsade de pointes)；
- （3）Patients have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females).
- （4）History or family history of congenital long QT syndrome；
- （5）Cardiac arrhythmias requiring anti-arrhythmic drug therapy (patients suffering from atrial fibrillation >1 month before the first administration of drug can be selected according to the condition of patients);
- （6）Left ventricular ejection fraction <50%；
- 15.Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
- 16.Patients who are not meet the inclusion criteria based on the judgment of investigator；
- 17.Patients included in dose-escalation and expansion study of combined chemotherapy should also exclude:
- Patients with gastric cancer, gastroesophageal junction adenocarcinoma who are allergic, intolerant or contraindicated to any other components of capecitabine and oxaliplatin.
- Patients with pancreatic cancer who are allergic, intolerant or contraindicated any components of gemcitabine and albumin bound paclitaxel for injection.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing cancer hospital
Beijing, Beijing Municipality, 100089
Linyi cancer hospital
Linyi, Shandong, 276000
About this study
This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Patients with gastric cancer/gastroesophageal junction adenocarcinoma and pancreatic cancer are preferred.
- Conditions
- Malignant Solid Tumor
- Being tested
- ASKB589 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKB589 InjectionDrug
ASKB589 Injection with dose escalation stage of 0.3mg/kg up to 20mg/kg,as well as dose expansion stage with recommended dose level from dose escalation stage.
| Study group | Role | What they receive |
|---|---|---|
| ASKB589 Injection | Experimental | Experimental: ASKB589 Injection ASKB589 Injection treatment. This phase 1/II trial will include two stages, a dose escalation stage and an expansion stage. Receives: Drug: ASKB589 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with serious adverse events (SAE) as assessed by CTCAE v5.0
An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; The number of participants who experience an SAE will be presented.
Measured: up to 21 days following last dose
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity，dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measured: up to 21 or 28 days following first dose
Number of participants with adverse events as assessed by CTCAE v5.0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Measured: up to 21 days following last dose
Maximum Tolerated Dose (MTD）
The MTD was defined as the highest dose of ASKB589 not causing DLT in more than 33% of patients in the first treatment cycle.
Measured: up to 21 or 28 days following first dose
The recommended dose
The recommended dose will be determined during the dose escalation and dose expansion stage of the study.
Measured: from date of treatment start until data cut-off, up to 2 years
Objective response rate
Evaluation of objective response rate assessed by response evaluation criteria in solid tumors version 1.1(RECIST 1.1)
Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Secondary outcomes (17)
Pharmacokinetics:maximum Plasma Concentration [Cmax]
Serum samples will be collected for Cmax analysis.
Measured: Up to 21 days after injection
Pharmacokinetics:time to maximum observed plasma concentration (Tmax)
Serum samples will be collected for Tmax analysis.
Measured: Up to 21 days after injection
Pharmacokinetics:elimination rate constant（Kel）
Serum samples will be collected for Kel analysis.
Measured: Up to 21 days after injection
Pharmacokinetics:terminal elimination half life (T1/2)
Serum samples will be collected for T1/2 analysis.
Measured: Up to 21 days after injection
Pharmacokinetics:apparent volume of distribution (Vz/F)
Serum samples will be collected for Vz/F analysis.
Measured: Up to 21 days after injection
Pharmacokinetics:Area Under Curve (AUC)
Serum samples will be collected for AUC analysis.
Measured: Up to 21 days after injection
Pharmacokinetics: Mean ResidenceTime（MRT）
Serum samples will be collected for MRT analysis.
Measured: Up to 21 days after injection
Pharmacokinetics: plasma clearance rate (CL)
Serum samples will be collected for CL analysis.
Measured: Up to 21 days after injection
Pharmacokinetics: steady-state peak concentration (Css_max)
Serum samples will be collected for Css_max analysis.
Measured: Up to 21 days after injection
Pharmacokinetics: time to steady-state peak concentration (Tss_max)
Serum samples will be collected for Tss_max analysis.
Measured: Up to 21 days after injection
Pharmacokinetics: minimum value of steady plasma drug concentration（Css_min）
Serum samples will be collected for Css max analysis.
Measured: Up to 21 days after injection
Evaluation of immunogenicity
Incidence of anti-drug antibodies (ADA)
Measured: from date of treatment start until data cut-off, up to 2 years
Objective response rate（ORR）
Evaluation of objective response rate assessed by RECIST 1.1
Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
disease control rate（DCR）
Evaluation of Disease control rate assessed by RECIST 1.1
Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Duration of Response（DOR）
Duration of response assessed by RECIST 1.1
Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Progression free survival（PFS）
Progression of tumor will be measured by RECIST v1.1
Measured: from date of treatment start until the date of disease progression or until death due to any causes, up to 2 years.
Overall survival（OS）
defined as the time from the date of treatment start until date of death due to any cause
Measured: from the date of treatment start until the documented date of death from any cause，up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start28 Jan 2021
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Biopharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632108
- Sponsor's protocol ID
- ASK-LC-B589-I/II
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04632108
- Acronym / sponsor ID
- ASK-LC-B589-I/II
- Conditions
- Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Biopharmaceutical Co., Ltd
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Nov 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.
This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Patients with gastric cancer/gastroesophageal junction adenocarcinoma and pancreatic cancer are preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASKB589 Injection | Experimental | Drug: ASKB589 InjectionExperimental: ASKB589 Injection ASKB589 Injection treatment. This phase 1/II trial will include two stages, a dose escalation stage and an expansion stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- According to RECIST 1.1 criteria, all patients must have at least one measurable lesion, and the tumor lesions must be accurately measured in at least one dimension, and lesions previously treated with radiotherapy or local therapy are only evaluated as non-target lesions. Bone metastatic lesions are not considered as measurable lesions;
- ECOG performance status (PS) 0-1;
- The results of the laboratory tests must meet all the following criteria:
- （1）Haemoglobin≥9 g/dL；platelet count≥ 100 × 109/L；absolute neutrophil count≥ 1.5 × 109/L；
- （2）Albumin≥ 3.0g/dL；total bilirubin ≤ 1.5 times the upper limit of normal (ULN)；aspartate transaminase and alanine aminotransferase≤ 2.5 times ULN if no demonstrable liver metastases ( ≤5 times ULN in the presence of liver metastases);
Key exclusion criteria (25 listed)
- Patients have a history of severe allergic reactions to monoclonal antibodies or are intolerance to monoclonal antibodies, or those who are allergic to experimental drug and any component of the drug.
- Patients have received a treatment of whole blood or blood component transfusion or various growth factor treatments within 14 days prior to enrollment.
- Patients have received anti-tumor therapy within 14 days prior to enrollment，including but not limited to radiotherapy, chemotherapy, targeted therapy, treatment with herbal medications or other treatments that have known antitumor activity . Patients who have undergone palliative radiotherapy for bone metastases and whose acute toxicity has returned to normal can be selected;
- Patients have received systemic immunosuppressive therapy（such as systemic corticosteroids）within 14 days prior to enrollment. However, patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30mg per day of hydrocortisone or 10mg per day of prednisone) are allowed；patients are allowed to receive a single dose of systemic corticosteroids treatment；
- Patients have participated in other clinical trials within 28 days prior to enrollment; patients who have participated monoclonal antibody clinical trials within 2 months prior to sign written informed consent form also cannot participate in this trial；
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 |
|---|---|---|
| ASKB589 InjectionASKB589 Injection with dose escalation stage of 0.3mg/kg up to 20mg/kg,as well as dose expansion stage with recommended dose level from dose escalation stage. | Drug | ASKB589 Injection |
Primary outcome
Number of participants with serious adverse events (SAE) as assessed by CTCAE v5.0
Time frame: up to 21 days following last dose
An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; The number of participants who experience an SAE will be presented.
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Time frame: up to 21 or 28 days following first dose
DLT is short for Dose Limiting Toxicity，dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: up to 21 days following last dose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Maximum Tolerated Dose (MTD）
Time frame: up to 21 or 28 days following first dose
The MTD was defined as the highest dose of ASKB589 not causing DLT in more than 33% of patients in the first treatment cycle.
The recommended dose
Time frame: from date of treatment start until data cut-off, up to 2 years
The recommended dose will be determined during the dose escalation and dose expansion stage of the study.
Objective response rate
Time frame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Evaluation of objective response rate assessed by response evaluation criteria in solid tumors version 1.1(RECIST 1.1)
17 secondary outcomes
Pharmacokinetics:maximum Plasma Concentration [Cmax]
Time frame: Up to 21 days after injection
Pharmacokinetics:time to maximum observed plasma concentration (Tmax)
Time frame: Up to 21 days after injection
Pharmacokinetics:elimination rate constant（Kel）
Time frame: Up to 21 days after injection
Pharmacokinetics:terminal elimination half life (T1/2)
Time frame: Up to 21 days after injection
Pharmacokinetics:apparent volume of distribution (Vz/F)
Time frame: Up to 21 days after injection
Pharmacokinetics:Area Under Curve (AUC)
Time frame: Up to 21 days after injection
Pharmacokinetics: Mean ResidenceTime（MRT）
Time frame: Up to 21 days after injection
Pharmacokinetics: plasma clearance rate (CL)
Time frame: Up to 21 days after injection
Pharmacokinetics: steady-state peak concentration (Css_max)
Time frame: Up to 21 days after injection
Pharmacokinetics: time to steady-state peak concentration (Tss_max)
Time frame: Up to 21 days after injection
Pharmacokinetics: minimum value of steady plasma drug concentration（Css_min）
Time frame: Up to 21 days after injection
Evaluation of immunogenicity
Time frame: from date of treatment start until data cut-off, up to 2 years
Objective response rate（ORR）
Time frame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
disease control rate（DCR）
Time frame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Duration of Response（DOR）
Time frame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
Progression free survival（PFS）
Time frame: from date of treatment start until the date of disease progression or until death due to any causes, up to 2 years.
Overall survival（OS）
Time frame: from the date of treatment start until the documented date of death from any cause，up to 2 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 11 Sep 2025.
- 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 1/2 study testing ASKB589 Injection in people with Malignant Solid Tumor, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. 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 25 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. 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 combined 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.
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?
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?
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 with serious adverse events (SAE) as assessed by CTCAE v5.0 (time frame: up to 21 days following last dose). The study lists 6 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 11 Sep 2025.