Solid TumorPhase 1/2NCT07392736
A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.
A Phase 1/2 study testing AL8326 tablets and Toripalimab in people with Solid Tumor, run by Advenchen Laboratories, LLC at 15 sites in China.
Trial summary
This trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AL8326 tablets and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 15 sitesChina
- Study dates
- 26 Oct 2021to 7 Nov 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
- Subjects must be able to understand and voluntarily sign a written informed consent form prior to the initiation of any study-related procedures.
- Age ≥ 18 years.
- Subjects with histologically confirmed advanced recurrent or metastatic solid tumors who meet one of the following conditions:
- Failure of standard therapy (disease progression after treatment or intolerance to treatment toxicity);
- no effective treatment available.
- Toripalimab monotherapy as a second-line or later standard treatment.
Show all 19Show fewer
- Must have at least one measurable lesion as defined by RECIST 1.1.
- Prior cytotoxic chemotherapy must have been completed at least 4 weeks before enrollment, and any toxicities must have recovered to ≤ Grade 1 (except alopecia).
- Life expectancy of ≥ 12 weeks at the time of enrollment.
- ECOG performance status of 0 or 1.
- Adequate organ function:
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1500/mm³); Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 9.0 g/dL.
- Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
- Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for subjects with Gilbert's syndrome); AST and ALT ≤ 2.5 × ULN in subjects without liver metastases, or ≤ 5 × ULN in subjects with liver metastases.
- Coagulation function: International normalized ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) > 50% during screening.
- Systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg (without medication or controlled with a single agent).
- Females: Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must agree to use medically acceptable methods of contraception during the treatment period and for 3 months after the last dose; The patient must be non-lactating; Postmenopausal women (≥ 12 months of amenorrhea without other causes) or surgically sterilized (oophorectomy and/or hysterectomy) are not considered of childbearing potential. Their partners must use medically acceptable contraception during the treatment period and for 3 months after the last dose. Males: Surgically sterile or must agree to use medically acceptable contraception during the treatment period and for 3 months after the last dose; Their partners must use medically acceptable contraception during the same period.
- Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
Who cannot join
- Received systemic cytotoxic therapy or investigational therapy within 28 days prior to initiation of study treatment, or non-cytotoxic, non-investigational therapy (e.g., radiotherapy, hormone therapy, targeted therapy, immunotherapy) within 14 days prior to initiation of study treatment.
- Major surgery (defined as requiring general anesthesia within 28 days before initiation of study treatment, or minor surgery requiring general anesthesia within 7 days before initiation of study treatment).
- Pregnant or lactating women.
- History of prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of safety or efficacy of the study treatment.
- Subjects with active or untreated central nervous system (CNS) metastases; Subjects with stable brain metastases may be enrolled if they meet the following criteria: a) No radiological evidence of progression for ≥ 4 weeks after completion of treatment; b) Completion of treatment ≥ 28 days before the first dose of study drug; c) No requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) within ≤ 14 days prior to the first dose of study drug.
- Active, known, or suspected autoimmune disease or interstitial lung disease.
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- Requirement for systemic therapy with corticosteroids or other immunosuppressive drugs within 14 days prior to initiation of study treatment.
- Peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with risk of perforation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to initiation of study treatment.
- Untreated deep vein thrombosis (DVT) within the past 6 months. Subjects with DVT treated with therapeutic anticoagulants (excluding therapeutic warfarin) for at least 14 days prior to initiation of study treatment are allowed.
- Uncontrolled infection.
- New York Heart Association (NYHA) Grade III or greater congestive heart failure.
- History of any of the following cardiac conditions within 6 months prior to initiation of study treatment:
- Cardiac angioplasty or stenting;
- Myocardial infarction;
- Unstable angina;
- Cerebrovascular accident.
- Presence of any unhealed wound, fracture, or ulcer, or symptomatic peripheral vascular disease.
- Evidence of hemorrhagic diathesis, coagulation disorder, or clinically significant bleeding (e.g., severe hematuria, gastrointestinal bleeding, hemoptysis) within 6 months prior to initiation of study treatment.
- QTcF ≥470 msec on screening ECG per Fridericia's formula.
- Urinalysis showing urine protein ≥ ++ and 24-hour urine protein quantification > 1.0 g within 28 days prior to initiation of study treatment.
- Positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the lower limit of detection of the local laboratory; Positive hepatitis C antibody (anti-HCV) with HCV-RNA above the lower limit of detection of the local laboratory; Positive syphilis antibody; Positive human immunodeficiency virus (HIV) antibody test.
- History of organ transplantation.
- Clinical conditions affecting the intake or absorption of AL8326 (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, malabsorption disorders, gastrectomy or small bowel resection).
- Use of prohibited concomitant medications within 14 days prior to initiation of study treatment.
- Receipt of red blood cell or platelet transfusion within 14 days prior to initiation of study treatment.
- Known allergy, hypersensitivity, or intolerance to protein therapies, or history of any severe drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia).
- Any severe and/or unstable pre-existing medical, psychiatric, or other condition that may jeopardize subject safety, obtaining informed consent, compliance with study procedures, or achievement of study objectives.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
National GCP Center for Anticancer Drugs,The Independent Ethics Committee
Beijing, Beijing Municipality, 100021
Dawei Wu, 01087788495, cancergcp@163.com
- Recruiting
The Cancer Hospital of the Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Dawei Wu, 010-87788495, cancergcp@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350001
Meimei Chen, 0591-62752181, fjzlec@163.com
- Recruiting
The First Affiliated Hospital of Guilin Medical Universty
Guilin, Guangxi
Rui Cai, 0773-2803369, fyywllwyh@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Meiyu Fang, 0571-88123728, zjchgcp@163.com
- Recruiting
SIR RUN RUN SHAW Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310016
Xu Ming, 0571-86006811, xm@srrsh.com
- Recruiting
Hunan Cancer Hospital
Hunan, Changsha, 410000
Hongkun Cai, 0731-89762695, hnszlyy_irb@163.com
- Recruiting
Liuzhou Workers' Hospital
Liuzhou, Guangxi
Zengqing Guo, 0772-3305029, lzsgryygcp@163.com
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530000
Shenhong Qu, 0771-5722415, qyylunli@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Hongping Yu, 0771-5330855, zlyyllb@163.com
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
Yi Jiang, 0754-88553278, zlyylunli@stu.edu.cn
- Recruiting
Yuebei People's Hospital
Shaoguan, Guangdong, 51200
Suming Pan, 0751-6913198, ybrmyyll@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710000
Qiuyue Yi, 029-85323473, xjyfyllh@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Ding Jing, 0371-65588251, dingjing201305@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Zhiheng Yang, 0371-66295219, yangzhgcp@163.com
About this study
Official title: A Phase I/IIa Clinical Trial of AL8326 Tablets Combined With Toripalimab in the Treatment of Advanced Recurrent or Metastatic Solid Tumors
This trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors
- Conditions
- Solid Tumor
- Being tested
- AL8326 tablets, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL8326 tabletsDrug
Also called AL8326
Tablet: 10mg/tablet; administered orally once daily
ToripalimabDrug
240mg Injection solution：21-Day cycles
| Study group | Role | What they receive |
|---|---|---|
| AL8326 plus toripalimab | Experimental | Phase 1: Cohort 1 will initiate with AL8326 +Toripalimab 240mg multiple dose (28-Day cycles) After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, further cohorts will be enrolled sequentially, following the same 28-day cycle regimen.
Phase 2a: Each subject will receive AL8326 +Toripalimab 240mg of this study for continuous 28-Day/21-Day cycles of therapy. AL8326 is orally administered daily at the RP2D found in Phase 1. Receives: Drug: AL8326 tablets; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first part (Phase I): Phase II recommended dose (RP2D)
Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.
Measured: At the end of Cycle 1 (each cycle is 28 days)
The second part (Phase IIa):Objective remission rate (ORR)
(ORR):The proportion of subjects achieving complete remission (CR) and partial remission (PR) with optimal efficacy according to RECIST 1.1.
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
Secondary outcomes (11)
The first part (Phase I): Objective remission rate (ORR)
(ORR):The proportion of subjects achieving complete remission (CR) and partial remission (PR) .
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Duration of remission (DOR)
(DOR):Description: The time between the start of the first assessment of the tumor as CR or PR and The first assessment of disease progression (PD) or death from any cause.
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Disease Control Rate (DCR)
(DCR): The proportion of subjects achieving complete remission (CR), partial remission (PR) and stable disease (SD).
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Duration of Disease Control (DDC)
(DDC): The time from the first assessment of the tumor as CR, PR, or SD to the first assessment of disease progression (PD) or death from any cause.
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Progression Free Survival (PFS)
(PFS): The period of time between the start of the subject's first dose of medication and the first observation of disease progression (based on imaging) or the occurrence of death due to any cause.
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Overall Survival (OS)
(OS): Defined as the time between the date of first dose and death from any cause. Subjects who are alive as of the date of analysis will use and the date they last achieved survival as the cutoff time.
Measured: Every 2 cycles,up to 24 months (each cycle is 28 days)
The second part (Phase IIa): Duration of remission (DOR)
(DOR):Description: The time between the start of the first assessment of the tumor as CR or PR and The first assessment of disease progression (PD) or death from any cause.
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Disease Control Rate (DCR)
(DCR): The proportion of subjects achieving complete remission (CR), partial remission (PR) and stable disease (SD).
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Duration of Disease Control (DDC)
(DDC): The time from the first assessment of the tumor as CR, PR, or SD to the first assessment of disease progression (PD) or death from any cause.
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Progression Free Survival (PFS)
(PFS): The period of time between the start of the subject's first dose of medication and the first observation of disease progression (based on imaging) or the occurrence of death due to any cause.
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Overall Survival (OS)
(OS): Defined as the time between the date of first dose and death from any cause. Subjects who are alive as of the date of analysis will use and the date they last achieved survival as the cutoff time.
Measured: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start26 Oct 2021
- Primary completion7 Nov 2029 (estimated)
- Study completion7 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing wang, Principal investigator, Hunan Cancer HospitalLingYIng Wu, Principal investigator, The Cancer Hospital of the Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392736
- Sponsor's protocol ID
- AL8326-CN-006
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial of AL8326 Tablets Combined With Toripalimab in the Treatment of Advanced Recurrent or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07392736
- Acronym / sponsor ID
- AL8326-CN-006
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Advenchen Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 7 Nov 2029 (estimated)
- Study completion
- 7 Nov 2029 (estimated)
- First posted
- 6 Feb 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 trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL8326 plus toripalimab | Experimental | Drug: AL8326 tablets, Drug: ToripalimabPhase 1: Cohort 1 will initiate with AL8326 +Toripalimab 240mg multiple dose (28-Day cycles) After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, further cohorts will be enrolled sequentially, following the same 28-day cycle regimen. Phase 2a: Each subject will receive AL8326 +Toripalimab 240mg of this study for continuous 28-Day/21-Day cycles of therapy. AL8326 is orally administered daily at the RP2D found in Phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must be able to understand and voluntarily sign a written informed consent form prior to the initiation of any study-related procedures.
- Age ≥ 18 years.
- Subjects with histologically confirmed advanced recurrent or metastatic solid tumors who meet one of the following conditions:
- Must have at least one measurable lesion as defined by RECIST 1.1.
- Prior cytotoxic chemotherapy must have been completed at least 4 weeks before enrollment, and any toxicities must have recovered to ≤ Grade 1 (except alopecia).
Key exclusion criteria (27 listed)
- Received systemic cytotoxic therapy or investigational therapy within 28 days prior to initiation of study treatment, or non-cytotoxic, non-investigational therapy (e.g., radiotherapy, hormone therapy, targeted therapy, immunotherapy) within 14 days prior to initiation of study treatment.
- Major surgery (defined as requiring general anesthesia within 28 days before initiation of study treatment, or minor surgery requiring general anesthesia within 7 days before initiation of study treatment).
- Pregnant or lactating women.
- History of prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of safety or efficacy of the study treatment.
- Subjects with active or untreated central nervous system (CNS) metastases; Subjects with stable brain metastases may be enrolled if they meet the following criteria: a) No radiological evidence of progression for ≥ 4 weeks after completion of treatment; b) Completion of treatment ≥ 28 days before the first dose of study drug; c) No requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) within ≤ 14 days prior to the first dose of study drug.
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 |
|---|---|---|
| AL8326 tabletsAlso: AL8326Tablet: 10mg/tablet; administered orally once daily | Drug | AL8326 plus toripalimab |
| Toripalimab240mg Injection solution：21-Day cycles | Drug | AL8326 plus toripalimab |
Primary outcome
The first part (Phase I): Phase II recommended dose (RP2D)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.
The second part (Phase IIa):Objective remission rate (ORR)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
(ORR):The proportion of subjects achieving complete remission (CR) and partial remission (PR) with optimal efficacy according to RECIST 1.1.
11 secondary outcomes
The first part (Phase I): Objective remission rate (ORR)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Duration of remission (DOR)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Disease Control Rate (DCR)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Duration of Disease Control (DDC)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Progression Free Survival (PFS)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The first part (Phase I): Overall Survival (OS)
Time frame: Every 2 cycles,up to 24 months (each cycle is 28 days)
The second part (Phase IIa): Duration of remission (DOR)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Disease Control Rate (DCR)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Duration of Disease Control (DDC)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Progression Free Survival (PFS)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
The second part (Phase IIa): Overall Survival (OS)
Time frame: Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）
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 6 Feb 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
Jing wang principal investigator
Hunan Cancer Hospital
LingYIng Wu principal investigator
The Cancer Hospital of the Chinese Academy of Medical Sciences
15 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 AL8326 tablets and Toripalimab in people with Solid Tumor, run by Advenchen Laboratories, LLC at 15 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 19 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Contact Jianbo Wu (13951647454, williamwujianbo@advenchen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first part (Phase I): Phase II recommended dose (RP2D) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.