Advanced Solid TumorsPhase 1/2NCT07509684
A Phase Ib/II Study Evaluating Injectable ALK-N001 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing ALK-N001 for Injection in people with Advanced Solid Tumors, run by Zhejiang Anglikang Pharmaceutical Co., Ltd..
Trial summary
This study is a multicenter, open-label, dose-escalation and cohort-expansion Phase Ib/II clinical trial conducted in patients with advanced solid tumors, aiming to evaluate the safety, pharmacokinetics and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced 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
- 190 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2029
- 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
- 1. Voluntarily signs the informed consent form, understands the study, and is willing and able to comply with all study procedures.
- 2. Male or female aged 18 years or older.
- 3. Has histologically and/or cytologically confirmed unresectable and/or metastatic advanced solid tumor.
- 4. Dose Expansion Phase (Phase Ib): Patients with advanced solid tumors who have failed standard treatment, currently have no standard treatment available, or are intolerant to standard treatment, including but not limited to lung cancer, pancreatic cancer, esophageal cancer, liver cancer, breast cancer (triple-negative breast cancer or HER2 low/ultra-low expression breast cancer), ovarian cancer, cervical cancer, and other tumor types.
- 5.Dose Expansion Phase (Phase II): Including but not limited to the following 4 cohorts: ① Lung Cancer Cohort (small cell lung cancer, non-squamous non-small cell lung cancer, squamous cell lung cancer): Failed at least one line of standard treatment; ② Breast Cancer Cohort (triple-negative breast cancer or HER2 low/ultra-low expression breast cancer): Failed at least one line of standard treatment; ③ Ovarian Cancer, Cervical Cancer, Pancreatic Cancer, and Liver Cancer Cohort: Failed at least one line of standard treatment; ④ Esophageal Cancer Cohort: Failed at least one line of standard treatment. There is documentation confirming radiologically confirmed disease progression after the last anti-tumor treatment. If a specific tumor type shows clear anti-tumor activity signals (e.g., meeting the preset efficacy threshold) during the Phase Ib study, the sponsor may initiate an additional dose expansion cohort for the effective tumor type during or after the Phase II study, to further verify its efficacy and safety.
- 6.According to RECIST Version 1.1, there is at least one measurable tumor lesion. (Tumor lesions located in previously irradiated areas or other locally treated sites are generally not considered measurable, unless there is clear evidence of progression of the lesion.)
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- 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 8. Expected survival time of ≥ 3 months.
- 9.Adequate organ function as follows: hematologic system (no blood transfusion or hematopoietic growth factor within 14 days): absolute neutrophil count ≥1.5×10⁹/L, platelets ≥90×10⁹/L, hemoglobin ≥90 g/L; liver function: total bilirubin ≤1.5×ULN, alanine aminotransferase ≤3×ULN (≤5×ULN in patients with liver metastasis or liver cancer), aspartate aminotransferase ≤3×ULN (≤5×ULN in patients with liver metastasis or liver cancer); renal function: creatinine ≤1.5×ULN, creatinine clearance ≥50 mL/min calculated by Cockcroft-Gault formula (required only if creatinine >1.5×ULN); coagulation function: activated partial thromboplastin time ≤1.5×ULN, international normalized ratio ≤1.5×ULN.
- 10. Male subjects and females of childbearing potential must agree to use non-pharmacological contraceptive measures from signing informed consent until 6 months after the last dose.
Who cannot join
- 1. Have received anti-tumor therapies such as chemotherapy, radiotherapy (local bone radiotherapy within 2 weeks), biological therapy, macromolecular targeted therapy, immunotherapy, or TIL cell therapy within 4 weeks prior to the first dose of the study drug, including the following: Have received anti-cancer endocrine therapy (excluding GnRH agonists or inhibitors, endocrine replacement therapy or contraceptives), oral fluoropyrimidines, small-molecule targeted drugs as well as traditional Chinese medicines with anti-tumor indications within 2 weeks or 5 half-lives prior to the first dose of the study drug (whichever is longer); Have received CAR-T, CAR-NK cell therapy or tumor vaccine therapy within 3 months prior to the use of the study drug; Have received inactivated viral vaccine injection within 2 weeks prior to the use of the study drug, or non-inactivated viral vaccine injection within 4 weeks prior to the use of the study drug; Have received other unlisted clinical trial drugs within 4 weeks or 5 half-lives prior to the use of the study drug (whichever is shorter);
- 2. Have used CYP3A4 strong inducers or strong inhibitors within 7 days prior to the first dose or need to use them during the study;
- 3. Have previously used DXD analogues, irinotecan and other drugs;
- 4. Have a known history of severe allergic reactions (NCI-CTCAE v6.0 grade ≥3) to the components of the preparations used in the trial;
- 5. Have central nervous system (CNS) metastases and/or leptomeningeal metastases; Study participants with treated brain metastases are allowed to participate in this study if the brain metastatic lesions have been stable for at least 1 month, there is no evidence of new or enlarged brain metastases, and steroid therapy has been discontinued for 2 weeks before the first dose;
- 6. Have other malignant tumors within 5 years before enrollment; Exceptions include cured carcinoma in situ of cervix, cutaneous squamous cell carcinoma, basal cell carcinoma or papillary thyroid carcinoma;
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- 7. Have clinically uncontrolled third-space effusions that are deemed unsuitable for enrollment by the investigator;
- 8. Have pre-existing severe digestive diseases such as chronic inflammatory bowel disease and/or intestinal obstruction or chronic diarrhea;
- 9. Have severe cardiovascular diseases, including but not limited to: a) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second to third-degree atrioventricular block, etc.; b) Acute coronary syndrome, congestive heart failure, stroke or other grade 3 and above cardiovascular events within 6 months before the first dose; c) New York Heart Association (NYHA) functional classification ≥ grade II or left ventricular ejection fraction (LVEF) <50%, or other structural heart diseases judged to be high-risk by the investigator; d) ECG examination showing QTcF >450ms (male), >470ms (female) (according to Fridericia formula: QTcF=QT/(RR^0.33)), (Note: If the initial examination is abnormal, re-measure twice within 48 hours and take the average of three measurements to judge eligibility); e) Clinically uncontrolled hypertension (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg after intervention); f) Poorly controlled diabetic patients defined as glycated hemoglobin (HbA1c) ≥8.0%;
- 10. Currently have active infections and have received systemic anti-infective treatment within 2 weeks before the first dose (excluding biopsy and prophylactic use for urinary tract surgery);
- 11. Have active hepatitis B during screening (HBsAg positive and HBV-DNA >500IU/ml or the lower limit of detection of the study center [only when the lower limit of detection of the study center is higher than 500IU/ml]), active hepatitis C (patients with positive HCV antibodies but HCV-RNA < the lower limit of detection of the study center are allowed to be enrolled); Patients receiving preventive antiviral treatment other than interferon are allowed to be enrolled; Patients with positive screening results for active syphilis or human immunodeficiency virus (HIV);
- 12. Have severe pulmonary diseases such as pulmonary embolism and interstitial lung disease within 6 months before the first dose;
- 13. Have a history of deep vein thrombosis or any other severe thromboembolism within 6 months before the first dose (implantable venous access port or catheter-related thrombosis, superficial venous thrombosis or lacunar infarction are not regarded as "severe" thromboembolism); Known familial and/or acquired thrombophilia, such as hereditary or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, or high thromboembolic risk due to acquired risk factors;
- 14. Have active hemorrhagic diseases or other grade ≥3 hemorrhage history within 4 weeks before the first dose; High bleeding risk caused by obvious invasion of large arteries by tumor metastases;
- 15. Toxic reactions from previous anti-tumor treatments have not recovered to ≤ grade 1 (severity assessed according to NCI-CTCAE v6.0, excluding alopecia and other toxicities judged to have no safety risks by the investigator) or the level specified in the inclusion criteria;
- 16. Currently receiving thrombolytic or anticoagulant therapy (excluding prophylactic anticoagulant therapy);
- 17. Have received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- 18. Have a history of mental disorders (including epilepsy or dementia, etc.);
- 19. Study participants have a history of drug abuse, or have medical, psychological or social conditions that may interfere with study participation or evaluation of study results;
- 20. Female study participants who are breastfeeding or have positive blood/urine pregnancy results during the screening period;
- 21. Any other conditions of the study participant (such as psychological, geographical or medical conditions) that do not allow them to comply with the study and follow-up procedures, or other circumstances where the study participant is deemed unsuitable for enrollment in this study by the investigator.
About this study
Official title: An Open-label, Multicenter Phase Ib/II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Injectable ALK-N001 in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, dose-escalation and cohort-expansion Phase Ib/II clinical trial conducted in patients with advanced solid tumors, aiming to evaluate the safety, pharmacokinetics and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- ALK-N001 for Injection
- Keywords
- AlK-N001, Advanced Solid Tumors, Phase Ib/II
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 QHL-1618, ALK-N001
The drug is administered via intravenous infusion at a constant rate over 2 hours ± 20 minutes. 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 (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), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. Receives: Drug: ALK-N001 for Injection |
| ALK-N001 (50 mg/m²) | Experimental | Participants will receive ALK-N001 for Injection at a dose of 50mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. 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), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. Receives: Drug: ALK-N001 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (15)
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.
PFS Rate at 6, 12, and 24 Months
The proportion of participants alive and free from disease progression at 6, 12, and 24 months after the first dose.
Measured: Through study completion, an average of 2 years.
OS Rate at 12 and 24 Months
The proportion of participants alive at 12 and 24 months after the first 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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
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
- NCT07509684
- Sponsor's protocol ID
- ALK-N001-002
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 13 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Injectable ALK-N001 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07509684
- Acronym / sponsor ID
- ALK-N001-002
- Conditions
- Advanced Solid Tumors
- Keywords
- AlK-N001, Advanced Solid Tumors, Phase Ib/II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 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 and cohort-expansion Phase Ib/II clinical trial conducted in patients with advanced solid tumors, aiming to evaluate the safety, pharmacokinetics and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. |
| ALK-N001 (50 mg/m²) | Experimental | Drug: ALK-N001 for InjectionParticipants will receive ALK-N001 for Injection at a dose of 50mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. |
| 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), once every 2 weeks (Q2W). A treatment cycle is defined as 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Voluntarily signs the informed consent form, understands the study, and is willing and able to comply with all study procedures.
- 2. Male or female aged 18 years or older.
- 3. Has histologically and/or cytologically confirmed unresectable and/or metastatic advanced solid tumor.
- 4. Dose Expansion Phase (Phase Ib): Patients with advanced solid tumors who have failed standard treatment, currently have no standard treatment available, or are intolerant to standard treatment, including but not limited to lung cancer, pancreatic cancer, esophageal cancer, liver cancer, breast cancer (triple-negative breast cancer or HER2 low/ultra-low expression breast cancer), ovarian cancer, cervical cancer, and other tumor types.
- 5.Dose Expansion Phase (Phase II): Including but not limited to the following 4 cohorts: ① Lung Cancer Cohort (small cell lung cancer, non-squamous non-small cell lung cancer, squamous cell lung cancer): Failed at least one line of standard treatment; ② Breast Cancer Cohort (triple-negative breast cancer or HER2 low/ultra-low expression breast cancer): Failed at least one line of standard treatment; ③ Ovarian Cancer, Cervical Cancer, Pancreatic Cancer, and Liver Cancer Cohort: Failed at least one line of standard treatment; ④ Esophageal Cancer Cohort: Failed at least one line of standard treatment. There is documentation confirming radiologically confirmed disease progression after the last anti-tumor treatment. If a specific tumor type shows clear anti-tumor activity signals (e.g., meeting the preset efficacy threshold) during the Phase Ib study, the sponsor may initiate an additional dose expansion cohort for the effective tumor type during or after the Phase II study, to further verify its efficacy and safety.
Key exclusion criteria (21 listed)
- 1. Have received anti-tumor therapies such as chemotherapy, radiotherapy (local bone radiotherapy within 2 weeks), biological therapy, macromolecular targeted therapy, immunotherapy, or TIL cell therapy within 4 weeks prior to the first dose of the study drug, including the following: Have received anti-cancer endocrine therapy (excluding GnRH agonists or inhibitors, endocrine replacement therapy or contraceptives), oral fluoropyrimidines, small-molecule targeted drugs as well as traditional Chinese medicines with anti-tumor indications within 2 weeks or 5 half-lives prior to the first dose of the study drug (whichever is longer); Have received CAR-T, CAR-NK cell therapy or tumor vaccine therapy within 3 months prior to the use of the study drug; Have received inactivated viral vaccine injection within 2 weeks prior to the use of the study drug, or non-inactivated viral vaccine injection within 4 weeks prior to the use of the study drug; Have received other unlisted clinical trial drugs within 4 weeks or 5 half-lives prior to the use of the study drug (whichever is shorter);
- 2. Have used CYP3A4 strong inducers or strong inhibitors within 7 days prior to the first dose or need to use them during the study;
- 3. Have previously used DXD analogues, irinotecan and other drugs;
- 4. Have a known history of severe allergic reactions (NCI-CTCAE v6.0 grade ≥3) to the components of the preparations used in the trial;
- 5. Have central nervous system (CNS) metastases and/or leptomeningeal metastases; Study participants with treated brain metastases are allowed to participate in this study if the brain metastatic lesions have been stable for at least 1 month, there is no evidence of new or enlarged brain metastases, and steroid therapy has been discontinued for 2 weeks before the first dose;
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: QHL-1618, ALK-N001The drug is administered via intravenous infusion at a constant rate over 2 hours ± 20 minutes. 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) |
Primary outcome
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 years.
The proportion of evaluable participants achieving a best overall response of Complete Response (CR) or Partial Response (PR).
15 secondary outcomes
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.
PFS Rate at 6, 12, and 24 Months
Time frame: Through study completion, an average of 2 years.
OS Rate at 12 and 24 Months
Time frame: Through study completion, an average of 2 years.
Incidence of Adverse Events (AEs)
Time frame: Through study completion, an average of 2 years.
Incidence of Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 2 years.
Incidence of AEs Leading to Permanent Treatment Discontinuation
Time frame: Through study completion, an average of 2 years.
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.
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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALK-N001 for Injection in people with Advanced Solid Tumors, run by Zhejiang Anglikang Pharmaceutical Co., Ltd..
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 10 inclusion and 21 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Objective Response Rate (ORR) (time frame: Through study completion, an average of 2 years.). 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 13 Apr 2026.