Advance Solid TumorsPhase 1NCT07529535
A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing ALK-N001 for Injection in people with Advance Solid Tumors, run by Zhejiang Anglikang Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, open-label, dose-escalation plus rollover and cohort expansion Phase I/II clinical trial conducted in patients with advanced solid tumors, including esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Solid Tumors
- What is being tested?
- ALK-N001 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria may be enrolled in this study:
- Voluntarily sign the informed consent form, understand the study, agree to comply with, and be capable of completing all trial procedures;
- Male or female aged 18 years or older;
- Unresectable and/or metastatic advanced solid tumor confirmed histologically and/or cytologically;
- Dose escalation + rollover phase (Phase Ia): Patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are intolerant to standard treatment (esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma are prioritized); Cohort expansion phase (Phase Ib/II): Divided into 4 cohorts: ① Esophageal squamous cell carcinoma cohort: Failed at least one line of standard treatment; ② Small cell lung cancer cohort: Failed at least one line of standard treatment; ③ Gastric/gastroesophageal junction adenocarcinoma cohort: Failed at least one line of standard treatment; ④ Other solid tumor cohort (the Sponsor and Investigator will jointly decide whether to initiate Cohort 4 and which indications to enroll based on the safety, pharmacokinetics, and efficacy results of the investigational product). Documented radiologically confirmed disease progression after the last anti-tumor therapy;
- At least one measurable tumor lesion according to RECIST version 1.1 (lesions in previously irradiated or other locally treated areas are generally not considered measurable unless clear progression is observed);
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- ECOG performance status 0-1;
- Life expectancy ≥ 3 months;
- Adequate organ function meeting the following criteria:
- Hematologic system (no blood transfusion or hematopoietic growth factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 90 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN;
- 5 × ULN for patients with liver metastasis or hepatocellular carcinoma Aspartate aminotransferase (AST) ≤ 3 × ULN;
- 5 × ULN for patients with liver metastasis or hepatocellular carcinoma Renal function Creatinine (Cr) ≤ 1.5 × ULN Creatinine clearance (Ccr) (calculated only if Cr > 1.5 × ULN) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
- Males and females of childbearing potential must agree to use non-pharmacological contraceptive measures from signing the informed consent form until 6 months after the last dose of study drug.
Who cannot join
- Subjects meeting any of the following criteria are ineligible for enrollment in this study:
- Received chemotherapy, radiotherapy (local bone radiotherapy within 2 weeks), biotherapy, macromolecular targeted therapy, immunotherapy, TIL cell therapy, or other anti-tumor treatments within 4 weeks prior to the first dose of study drug, except:
- Received anti-cancer endocrine therapy (excluding GnRH agonists or antagonists, endocrine replacement therapy, or contraceptives), oral fluoropyrimidines, small-molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications within 2 weeks or 5 half-lives (whichever is longer) prior to the first study drug dose;
- Received CAR-T, CAR-NK cell therapy, or tumor vaccine therapy within 3 months prior to study drug administration;
- Received inactivated viral vaccine within 2 weeks or non-inactivated viral vaccine within 4 weeks prior to study drug administration;
- Received other uninvestigational investigational medicinal products within 4 weeks or 5 half-lives (whichever is shorter) prior to study drug administration.
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- Used strong CYP3A4 inducers or strong inhibitors within 7 days before the first dose, or requires such agents during the study period.
- Known severe hypersensitivity to any component of the investigational product (NCI-CTCAE v5.0 grade ≥ 3).
- Presence of central nervous system (CNS) metastases and/or leptomeningeal metastases.
- Subjects with treated brain metastases may be enrolled if lesions are stable for at least 1 month with no new or enlarging lesions, and steroid therapy has been discontinued for 2 weeks before the first dose.
- Diagnosis of another malignancy within 5 years prior to enrollment, except cured carcinoma in situ of the cervix, squamous cell carcinoma of the skin, basal cell carcinoma, or papillary thyroid carcinoma.
- Clinically uncontrolled third-space fluid effusion deemed inappropriate by the investigator.
- History of severe gastrointestinal disorders including chronic inflammatory bowel disease, intestinal obstruction, or chronic diarrhea.
- Severe cardiovascular disease, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, 2nd-3rd degree atrioventricular block);
- Acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade ≥3 within 6 months prior to first dose;
- New York Heart Association (NYHA) functional class ≥ II, left ventricular ejection fraction (LVEF) < 50%, or other structural heart disease at high risk as judged by the investigator;
- QTcF > 450 ms (males), > 470 ms (females) on ECG (calculated by Fridericia formula: QTcF = QT/(RR^0.33)).
- Note: If initial screening is abnormal, repeat twice within 48 hours; eligibility determined by the mean of three measurements.
- Clinically uncontrolled hypertension (systolic BP ≥ 150 mmHg and/or diastolic BP ≥ 100 mmHg despite intervention);
- Poorly controlled diabetes defined as HbA1c ≥ 8.0%.
- Active infection at screening, or systemic anti-infective treatment within 2 weeks before first dose (excluding biopsy prophylaxis and urological surgery prophylaxis).
- Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml or above the local laboratory lower limit [if local LL > 500 IU/ml]); active hepatitis C (HCV antibody positive, but patients with HCV-RNA below local LL are eligible). Patients receiving prophylactic antiviral therapy other than interferon are allowed.
- Active syphilis or positive HIV screening.
- Severe pulmonary disease (e.g., pulmonary embolism, interstitial lung disease) within 6 months prior to first dose.
- History of deep vein thrombosis or any severe thromboembolism within 6 months before first dose (implanted venous port/catheter-related thrombosis, superficial venous thrombosis, or lacunar infarction are not considered severe).
- Known familial and/or acquired thrombophilia (hereditary or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, or high thrombotic risk due to acquired risk factors).
- Active hemorrhagic disease or bleeding history of grade ≥3 within 4 weeks before first dose; high bleeding risk due to tumor invasion of large arteries.
- Toxicity from prior anti-tumor therapy not recovered to grade ≤1 (per NCI-CTCAE v5.0; exceptions include alopecia or other toxicities deemed safe by the investigator) or the level specified in inclusion criteria.
- Receiving thrombolytic or anticoagulant therapy (excluding prophylactic anticoagulation).
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of psychiatric disorders (including epilepsy, dementia, etc.).
- History of substance abuse, or any medical, psychological, or social condition that may interfere with study participation or outcome assessment.
- Female subjects who are breastfeeding or have a positive blood/urine pregnancy test during screening.
- Any other condition (medical, psychological, geographic, etc.) that prevents compliance with study and follow-up procedures, or any other situation in which the investigator deems the subject unsuitable for enrollment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhejiang Cancer Hospital
Hangzhou, 310022
Zhongshan Hospital, Fudan University
Shanghai, 200032
About this study
Official title: An Open-label, Multicenter, Dose-escalationStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALK-N001 for Injection in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, dose-escalation plus rollover and cohort expansion Phase I/II clinical trial conducted in patients with advanced solid tumors, including esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma.
- Conditions
- Advance Solid Tumors
- Being tested
- ALK-N001 for Injection
- Keywords
- ALK-N001, Advanced solid tumors, Phase Ia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK-N001 for InjectionDrug
Also called ALK-N001, QHL-1618
The drug is administered via intravenous infusion at a constant rate . The primary dosing schedule was every 2 weeks (Q2W) in a 28-day cycle, while an every 3 weeks (Q3W) schedule with a 21-day cycle was also explored.
| Study group | Role | What they receive |
|---|---|---|
| ALK-N001（7.5 mg/m2） | Experimental | Participants will receive ALK-N001 for Injection at a dose of 7.5 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). Receives: Drug: ALK-N001 for Injection |
| ALK-N001（15 mg/m2） | Experimental | Participants will receive ALK-N001 for Injection at a dose of 15 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). Receives: Drug: ALK-N001 for Injection |
| ALK-N001（25 mg/m2） | Experimental | Participants will receive ALK-N001 for Injection at a dose of 25 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). Receives: Drug: ALK-N001 for Injection |
| ALK-N001 (37.5 mg/m²) | Experimental | Participants will receive ALK-N001 for Injection at a dose of 37.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). Receives: Drug: ALK-N001 for Injection |
| ALK-N001 (50 mg/m²) | Experimental | Participants will receive ALK-N001 for Injection at a dose of 50 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). Receives: Drug: ALK-N001 for Injection |
| ALK-N001 (62.5 mg/m²) | Experimental | Participants will receive ALK-N001 for Injection at a dose of 62.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). Receives: Drug: ALK-N001 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity（DLT）
The occurrence of DLT, and determine Maximum Tolerated Dose or Recommended Phase 2 Dose.
Measured: Through study completion, an average of 2 years
Incidence of Adverse Events (AEs)
Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of alladverse events (AEs) .
Measured: Through study completion, an average of 2 years
Incidence of Serious Adverse Events (SAEs)
Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of serious adverse events (SAEs).
Measured: Through study completion, an average of 2 years
Incidence of AEs Leading to Permanent Treatment Discontinuation
Frequency of AEs that result in permanent discontinuation of the study drug.
Measured: Through study completion, an average of 2 years
Secondary outcomes (12)
Area Under the Curve (AUC) of ALK-N001
Area under the plasma concentration-time curve for ALK-N001.
Measured: Through study completion, an average of 2 years
Maximum Concentration (Cmax) of ALK-N001
Maximum observed plasma concentration of ALK-N001.
Measured: Through study completion, an average of 2 years
Trough Concentration (Ctrough) of ALK-N001
Trough plasma concentration of ALK-N001.
Measured: Through study completion, an average of 2 years
Time to Maximum Concentration (Tmax) of ALK-N001
Time to reach the maximum plasma concentration of ALK-N001.
Measured: Through study completion, an average of 2 years
Clearance (CL) of ALK-N001
Systemic clearance of ALK-N001.
Measured: Through study completion, an average of 2 years
Volume of Distribution (Vd) of ALK-N001
Volume of distribution of ALK-N001.
Measured: Through study completion, an average of 2 years
Mean Residence Time（MRT )
The average residence time of ALK-N001 in the body.
Measured: Through study completion, an average of 2 years
Objective Response Rate (ORR)
The proportion of evaluable participants achieving a best overall response of Complete Response (CR) or Partial Response (PR).
Measured: Through study completion, an average of 2 years
Disease Control Rate (DCR)
Proportion of evaluable participants with a best overall response of CR, PR, or Stable Disease (SD).
Measured: Through study completion, an average of 2 years
Duration of Response (DOR)
Time from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause.
Measured: Through study completion, an average of 2 years
Progression-Free Survival (PFS)
Time from the date of first dose to the date of first documented disease progression or death due to any cause.
Measured: Through study completion, an average of 2 years
Overall Survival (OS)
Time from the date of first dose to the date of death due to any cause.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start5 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Participant recruitment has been stopped because the planned sample size has been reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529535
- Sponsor's protocol ID
- ALK-N001-001
- Other IDs
- CTR20252185
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Dose-escalationStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALK-N001 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07529535
- Acronym / sponsor ID
- ALK-N001-001
- Conditions
- Advance Solid Tumors
- Keywords
- ALK-N001, Advanced solid tumors, Phase Ia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Participant recruitment has been stopped because the planned sample size has been reached.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Apr 2026 (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 multicenter, open-label, dose-escalation plus rollover and cohort expansion Phase I/II clinical trial conducted in patients with advanced solid tumors, including esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALK-N001（7.5 mg/m2） | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 7.5 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). |
| ALK-N001（15 mg/m2） | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 15 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). |
| ALK-N001（25 mg/m2） | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 25 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes). |
| ALK-N001 (37.5 mg/m²) | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 37.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). |
| ALK-N001 (50 mg/m²) | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 50 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). |
| ALK-N001 (62.5 mg/m²) | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 62.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects meeting all of the following criteria may be enrolled in this study:
- Hematologic system (no blood transfusion or hematopoietic growth factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 90 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN;
Key exclusion criteria (35 listed)
- Subjects meeting any of the following criteria are ineligible for enrollment in this study:
- Received chemotherapy, radiotherapy (local bone radiotherapy within 2 weeks), biotherapy, macromolecular targeted therapy, immunotherapy, TIL cell therapy, or other anti-tumor treatments within 4 weeks prior to the first dose of study drug, except:
- Used strong CYP3A4 inducers or strong inhibitors within 7 days before the first dose, or requires such agents during the study period.
- Known severe hypersensitivity to any component of the investigational product (NCI-CTCAE v5.0 grade ≥ 3).
- Presence of central nervous system (CNS) metastases and/or leptomeningeal metastases.
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 |
|---|---|---|
| ALK-N001 for InjectionAlso: ALK-N001, QHL-1618The drug is administered via intravenous infusion at a constant rate . The primary dosing schedule was every 2 weeks (Q2W) in a 28-day cycle, while an every 3 weeks (Q3W) schedule with a 21-day cycle was also explored. | Drug | ALK-N001 (37.5 mg/m²), ALK-N001 (50 mg/m²), ALK-N001 (62.5 mg/m²), ALK-N001（15 mg/m2）, ALK-N001（25 mg/m2）, ALK-N001（7.5 mg/m2） |
Primary outcome
Dose-Limiting Toxicity（DLT）
Time frame: Through study completion, an average of 2 years
The occurrence of DLT, and determine Maximum Tolerated Dose or Recommended Phase 2 Dose.
Incidence of Adverse Events (AEs)
Time frame: Through study completion, an average of 2 years
Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of alladverse events (AEs) .
Incidence of Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 2 years
Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of serious adverse events (SAEs).
Incidence of AEs Leading to Permanent Treatment Discontinuation
Time frame: Through study completion, an average of 2 years
Frequency of AEs that result in permanent discontinuation of the study drug.
12 secondary outcomes
Area Under the Curve (AUC) of ALK-N001
Time frame: Through study completion, an average of 2 years
Maximum Concentration (Cmax) of ALK-N001
Time frame: Through study completion, an average of 2 years
Trough Concentration (Ctrough) of ALK-N001
Time frame: Through study completion, an average of 2 years
Time to Maximum Concentration (Tmax) of ALK-N001
Time frame: Through study completion, an average of 2 years
Clearance (CL) of ALK-N001
Time frame: Through study completion, an average of 2 years
Volume of Distribution (Vd) of ALK-N001
Time frame: Through study completion, an average of 2 years
Mean Residence Time（MRT )
Time frame: Through study completion, an average of 2 years
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 years
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 2 years
Duration of Response (DOR)
Time frame: Through study completion, an average of 2 years
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 2 years
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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 study testing ALK-N001 for Injection in people with Advance Solid Tumors, run by Zhejiang Anglikang 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 13 inclusion and 35 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: paused, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 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 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?
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） (time frame: Through study completion, an average of 2 years). The study lists 4 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 17 Apr 2026.