Solid Tumor CancerPhase 1/2NCT06848699
A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing HLX43 dose 1, HLX43 dose 2 and HLX43 dose 3 in people with Solid Tumor Cancer and Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 3 sites in China.
Trial summary
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Cancer, Non Small Cell Lung Cancer
- What is being tested?
- HLX43 dose 1, HLX43 dose 2 and HLX43 dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesChina
- Study dates
- 25 Feb 2025to 1 Oct 2027
- 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
- Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing and able to comply with and complete all trial procedures;
- Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;
- Phase Ib enrollment of patients with histologically or cytologically confirmed advanced /metastatic solid tumor who have experienced treatment failure or for whom no standard treatment is available;Phase II enrollment includes advanced /metastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI or/and platinum-based chemotherapy.
- Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;
- Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.
- The ECOG PS score within 7 days prior to the first use of the Investigational Product is 0 or 1;
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- Expected survival ≥ 12 weeks;
- Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received):
- Female subjects of childbearing potential must meet the following criteria:
- a)The blood pregnancy test must be negative within 7 days prior to the first administration of the medication; b)Agree to use at least one highly effective method of contraception during the trial period and for at least 6 months after the last administration of the drug;c)Breastfeeding is contraindicated.
- Male subjects must meet the following criteria: agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose.
Who cannot join
- History of any second malignancy within 3 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
- Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.
- Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;
- Subjects with clinical symptoms of brain metastases, spinal cord compression, meningitis carcinomatosa, or other evidence indicating that brain or spinal cord metastatic lesions are not yet controlled; Note: Subjects with asymptomatic or stable brain metastases, spinal cord compression, or meningitis carcinomatosa as determined by theinvestigator may be eligible for enrollment;
- Subjects with a history or current condition of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function, as determined by the sub investigator, that may interfere with the detection and management of suspected drug-related pulmonary toxicity;
- The subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure or left ventricular ejection fraction (LVEF) <50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the past 6 months (excluding lacunar infarction, minor cerebral ischaemia, or transient ischaemic attack); (4) uncontrolled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females, with QTc interval calculated using the Fridericia formula); (5) poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite active treatment);
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- History of immunodeficiency diseases, including testing positive for human immunodeficiency virus (HIV), or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
- Has active pulmonary tuberculosis;
- Subjests with active HBV, HCV infection or co-infection;
- There is a known active or suspected autoimmune disease. Enrollment is allowed for subjects in a stable condition who do not require systemic immunosuppressive therapy.
- Subjects requiring systemic corticosteroids (>10 mg/day prednisone therapeutic dosage) or other immunosuppressive drug therapy within 14 days prior to the first administration of the Investigational Product or during the study. However, the following situations allow for enrollment: in the absence of active autoimmune disorders, the use of topical external application or inhaled steroids and adrenal hormone replacement therapy at a dosage ≤10 mg/day prednisone therapeutic dosage is permitted; prophylactic medication is allowed.
- Any active infection requiring systemic anti-infective therapy within 14 days prior to the first administration of the Investigational Product;
- Within 28 days prior to the first administration of the Investigational Product, the subject has undergone major surgery. In this study, major surgery is defined as a procedure requiring at least 3 weeks of postoperative recovery before being eligible to receive treatment in this study. Tumor paracentesis or lymph node incisional biopsy is permitted for enrollment.
- Strong inhibitors or strong inducers of CYP2D6 or CYP3A were used within 2 weeks prior to the first administration of the drug.
- Received live viral vaccine treatment within 28 days prior to the first administration of the Investigational Product; however, inactivated viral vaccines for seasonal flu and novel coronavirus are permitted;
- Participating in another clinical trial or planning to start this study with less than 14 days since the end-of-therapy of the previous clinical trial; less than 5 half-lives since the last course of anti-tumor therapy;
- Known to have a severe allergy to any monoclonal antibody;
- Subjects who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Second Affiliated Hospital of Army Medical University, PLA
Chongqing, 400000
Bo Zhu, Dr
- Recruiting
Hunan Provincial Cancer Hospital
Hunan, Changsha, 410031
Lin Wu, Dr, 0731-89766300, wulin-calf@vip.163.com
Lin Wu, Dr
- Recruiting
Shandong Cancer Hospital
Jinan, Shangdong
About this study
Official title: A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors
Read the detailed description
This study is an open-label phase Ib/II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in Patients with advanced/metastatic solid tumors. The study is divided into two phases: phase Ib dose escalation and phase II dose expansion.The subjects will receive different dosages of HLX43 combined with a fixed dosage (300 mg) of serplulimab, administered via intravenous infusion every 3 weeks (Q3W) .
- Conditions
- Solid Tumor Cancer, Non Small Cell Lung Cancer
- Being tested
- HLX43 dose 1, HLX43 dose 2, HLX43 dose 3, HLX43 dose 4, HLX43 dose 5
- Keywords
- HLX43
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43 dose 1Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 dose 2Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 dose 3Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 dose 4Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 dose 5Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
SerplulimabDrug
anti-PD-1 humanized monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| HLX43 dose 1 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 1; Drug: Serplulimab |
| HLX43 dose 2 | Experimental | : Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 2; Drug: Serplulimab |
| HLX43 dose 3 | Experimental | : Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 3; Drug: Serplulimab |
| HLX43 dose 4 | Experimental | : Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 4; Drug: Serplulimab |
| HLX43 dose 5 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 5; Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
The proportion of subjects experiencing dose-limiting toxicity (DLT) events in each dosage group during the DLT observation period
Measured: 21 days after the first dose
MTD
The maximum tolerated dose of HLX43 incombination with serplulimab
Measured: through study completion, an average of 12 months
ORR
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
Secondary outcomes (6)
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
Measured: from the date of the first dose to to 90 days after the last dose or the initiation of another anticancer treatment (whichever occurs first).
RP2/3D
RP2/3D of HLX43 combined with serplulimab in NSCLC patients
Measured: through study completion, an average of 12 months
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
ORR
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
Measured: up to 24 week
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start25 Feb 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848699
- Sponsor's protocol ID
- HLX43HLX10-ST201
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06848699
- Acronym / sponsor ID
- HLX43HLX10-ST201
- Conditions
- Solid Tumor Cancer, Non Small Cell Lung Cancer
- Keywords
- HLX43
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 27 Feb 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.
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors
Detailed description
This study is an open-label phase Ib/II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in Patients with advanced/metastatic solid tumors. The study is divided into two phases: phase Ib dose escalation and phase II dose expansion.The subjects will receive different dosages of HLX43 combined with a fixed dosage (300 mg) of serplulimab, administered via intravenous infusion every 3 weeks (Q3W) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HLX43 dose 1 | Experimental | Drug: HLX43 dose 1, Drug: SerplulimabPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 dose 2 | Experimental | Drug: HLX43 dose 2, Drug: Serplulimab: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 dose 3 | Experimental | Drug: HLX43 dose 3, Drug: Serplulimab: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 dose 4 | Experimental | Drug: HLX43 dose 4, Drug: Serplulimab: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 dose 5 | Experimental | Drug: HLX43 dose 5, Drug: SerplulimabPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing and able to comply with and complete all trial procedures;
- Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;
- Phase Ib enrollment of patients with histologically or cytologically confirmed advanced /metastatic solid tumor who have experienced treatment failure or for whom no standard treatment is available;Phase II enrollment includes advanced /metastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI or/and platinum-based chemotherapy.
- Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;
- Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.
Key exclusion criteria (18 listed)
- History of any second malignancy within 3 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
- Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.
- Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;
- Subjects with clinical symptoms of brain metastases, spinal cord compression, meningitis carcinomatosa, or other evidence indicating that brain or spinal cord metastatic lesions are not yet controlled; Note: Subjects with asymptomatic or stable brain metastases, spinal cord compression, or meningitis carcinomatosa as determined by theinvestigator may be eligible for enrollment;
- Subjects with a history or current condition of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function, as determined by the sub investigator, that may interfere with the detection and management of suspected drug-related pulmonary toxicity;
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 |
|---|---|---|
| HLX43 dose 1HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 dose 1 |
| HLX43 dose 2HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 dose 2 |
| HLX43 dose 3HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 dose 3 |
| HLX43 dose 4HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 dose 4 |
| HLX43 dose 5HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 dose 5 |
| Serplulimabanti-PD-1 humanized monoclonal antibody injection | Drug | HLX43 dose 1, HLX43 dose 2, HLX43 dose 3, HLX43 dose 4, HLX43 dose 5 |
Primary outcome
DLT
Time frame: 21 days after the first dose
The proportion of subjects experiencing dose-limiting toxicity (DLT) events in each dosage group during the DLT observation period
MTD
Time frame: through study completion, an average of 12 months
The maximum tolerated dose of HLX43 incombination with serplulimab
ORR
Time frame: up to 24 weeks
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
6 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: from the date of the first dose to to 90 days after the last dose or the initiation of another anticancer treatment (whichever occurs first).
RP2/3D
Time frame: through study completion, an average of 12 months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
ORR
Time frame: up to 24 week
OS
Time frame: From randomization to death from any cause (up to approximately 25 months)
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 17 Nov 2025.
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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.
3 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 HLX43 dose 1, HLX43 dose 2 and HLX43 dose 3 in people with Solid Tumor Cancer and Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 3 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 11 inclusion and 18 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Bo Zhu, Dr (86-023-68755626, bo.zhu@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 21 days after the first dose). The study lists 3 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 Nov 2025.