Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2NCT07235202
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
A Phase 1/2 study testing MR001, Irinotecan Liposome Injection combined with 5-FU/LV and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shenzhen Majory Biotechnology Co., Ltd. at 18 sites in China.
Trial summary
This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- MR001, Irinotecan Liposome Injection combined with 5-FU/LV and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 18 sitesChina
- Study dates
- 24 Dec 2025to 22 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG Performance Status of 0-1.
- Life expectancy >3 months.
- Adequate organ and marrow function as defined by laboratory parameters.
- Voluntarily sign the informed consent form.
Who cannot join
- Known hypersensitivity to MR001 or similar monoclonal antibodies.
- Requirement for systemic immunosuppressive therapy within 14 days before first dosing.
- Uncontrolled active infections or concurrent malignancies.
- Not adequately controlled active brain metastases or leptomeningeal metastasis.
- Clinically significant cardiovascular, renal, or hepatic disorders.
- Pregnant or breastfeeding women.
- Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Jiahong Dong, MD, PhD, +86-10-56118899, dongjiahong@mail.tsinghua.edu.cn
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130015
Wei Li, PhD, +86 13756661267, jdyylw@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Zhenyang Liu, +86 18673181133, Liuzhenyang@hnca.org.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xuelei Ma, +86 18980607330, 183818128@qq.com
Ke Cheng, +86 13408410416, mxlmax@163.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Dewei Li, +86 13618317772, lidewei406@sina.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Zengqing Guo, +86 13905918836, gzq_005@126.com
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Zhihua Li, +86 13710818805, lzhdoct@163.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, +86 13858195803, hzyingjieer@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, PhD, +86 15134569619, yqbfzhengtongsen@163.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Shuqin Ni, +86 15553115936, nsq163@163.com
Zuoxing Niu
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Zan Teng, +86 13704012815, tengzan@163.com
- Not yet recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Hua Cao, +86 13823518246, caohua1206@hotmail.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen
Shenzhen, Guangdong, 518172
Junjie Hang, +86 13681709736, katerhjj0000@126.com
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Fei Yin, +86 13831120022, yinfei_4y@sina.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heshui Wu, +86 13720117761, heshuiwu@hust.edu.cn
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hong Qiu, +86 13986296106, tjqiuhong@163.com
- Not yet recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Kaijian Lei, +86 13990903661, lkj600@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Xiaobing Chen, +86 13937100233, 2290773710@qq.com
About this study
Official title: An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy
This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.
Read the detailed description
This is an open-label, dose-escalation and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- MR001, Irinotecan Liposome Injection combined with 5-FU/LV, Nab-paclitaxel, Gemcitabine (GEM)
- Keywords
- MR001, PDAC, CD4, TGF-β1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR001Drug
Intravenous infusion
Irinotecan Liposome Injection combined with 5-FU/LVDrug
Per locally approved formulation
Nab-paclitaxelDrug
Per locally approved formulation
Gemcitabine (GEM)Drug
Per locally approved formulation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU | Experimental | MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV |
| Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU | Experimental | MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV |
| Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU | Experimental | MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV |
| Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine | Experimental | MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Nab-paclitaxel; Drug: Gemcitabine (GEM) |
| Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine | Experimental | MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Nab-paclitaxel; Drug: Gemcitabine (GEM) |
| Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine | Experimental | MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Receives: Drug: MR001; Drug: Nab-paclitaxel; Drug: Gemcitabine (GEM) |
| Dose Expansion Part | Experimental | Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study Receives: Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV; Drug: Nab-paclitaxel; Drug: Gemcitabine (GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Measured: Approximately 12 months
Maximum Tolerated Dose (MTD) of MR001
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Measured: Approximately 12 months
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Measured: Approximately 30 months
Objective Response Rate (ORR)
Measured: Approximately 24 months
Best Overall Response (BOR)
Measured: Approximately 24 months
Disease control rate (DCR)
Measured: Approximately 24 months
Secondary outcomes (11)
Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Measured: Approximately 12 months
Progressionfree survival (PFS)
Measured: Approximately 24 months
Overall survival (OS)
Measured: Approximately 30 months
Area Under the Plasma ConcentrationTime Curve (AUC) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Maximum Plasma Concentration (Cmax) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Half-life (T1/2) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Incidence of Antidrug Antibodies (ADA) to MR001
Measured: Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for Th1 in plasma
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for Th2 in plasma
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for TGF-β1 in plasma
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for CD4 in plasma
Measured: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start24 Dec 2025
- Primary completion22 Jun 2028 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235202
- Sponsor's protocol ID
- MJR-MR001-02
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy
- ClinicalTrials.gov ID
- NCT07235202
- Acronym / sponsor ID
- MJR-MR001-02
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- MR001, PDAC, CD4, TGF-β1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shenzhen Majory Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 22 Dec 2028 (estimated)
- First posted
- 19 Nov 2025 (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 Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.
Detailed description
This is an open-label, dose-escalation and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU | Experimental | Drug: MR001, Drug: Irinotecan Liposome Injection combined with 5-FU/LVMR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration |
| Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU | Experimental | Drug: MR001, Drug: Irinotecan Liposome Injection combined with 5-FU/LVMR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration |
| Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU | Experimental | Drug: MR001, Drug: Irinotecan Liposome Injection combined with 5-FU/LVMR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration |
| Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine | Experimental | Drug: MR001, Drug: Nab-paclitaxel, Drug: Gemcitabine (GEM)MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration |
| Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine | Experimental | Drug: MR001, Drug: Nab-paclitaxel, Drug: Gemcitabine (GEM)MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration |
| Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine | Experimental | Drug: MR001, Drug: Nab-paclitaxel, Drug: Gemcitabine (GEM)MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration |
| Dose Expansion Part | Experimental | Drug: MR001, Drug: Irinotecan Liposome Injection combined with 5-FU/LV, Drug: Nab-paclitaxel, Drug: Gemcitabine (GEM)Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG Performance Status of 0-1.
- Life expectancy >3 months.
- Adequate organ and marrow function as defined by laboratory parameters.
Key exclusion criteria (7 listed)
- Known hypersensitivity to MR001 or similar monoclonal antibodies.
- Requirement for systemic immunosuppressive therapy within 14 days before first dosing.
- Uncontrolled active infections or concurrent malignancies.
- Not adequately controlled active brain metastases or leptomeningeal metastasis.
- Clinically significant cardiovascular, renal, or hepatic disorders.
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 |
|---|---|---|
| MR001Intravenous infusion | Drug | Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU, Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU, Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU, Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine, Dose Expansion Part |
| Irinotecan Liposome Injection combined with 5-FU/LVPer locally approved formulation | Drug | Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU, Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU, Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU, Dose Expansion Part |
| Nab-paclitaxelPer locally approved formulation | Drug | Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine, Dose Expansion Part |
| Gemcitabine (GEM)Per locally approved formulation | Drug | Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine, Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine, Dose Expansion Part |
Primary outcome
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time frame: Approximately 12 months
Maximum Tolerated Dose (MTD) of MR001
Time frame: Approximately 12 months
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Time frame: Approximately 30 months
Objective Response Rate (ORR)
Time frame: Approximately 24 months
Best Overall Response (BOR)
Time frame: Approximately 24 months
Disease control rate (DCR)
Time frame: Approximately 24 months
11 secondary outcomes
Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Time frame: Approximately 12 months
Progressionfree survival (PFS)
Time frame: Approximately 24 months
Overall survival (OS)
Time frame: Approximately 30 months
Area Under the Plasma ConcentrationTime Curve (AUC) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Maximum Plasma Concentration (Cmax) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Half-life (T1/2) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Incidence of Antidrug Antibodies (ADA) to MR001
Time frame: Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for Th1 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for Th2 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for TGF-β1 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for CD4 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
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 Nov 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.
18 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 MR001, Irinotecan Liposome Injection combined with 5-FU/LV and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shenzhen Majory Biotechnology Co., Ltd. at 18 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 6 inclusion and 7 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 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 Qingshan Xue (+86 13332895357, xueqs@majory.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience one or more dose-limiting toxicities (DLTs) (time frame: Approximately 12 months). 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 6 Nov 2026.