Breast Cancer (Locally Advanced or Metastatic)Phase 1/2NCT07738341
GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)
A Phase 1/2 study testing GB268, Nab-Paclitaxel and Datopotamab Deruxtecan (Dato-DXd) in people with Breast Cancer (Locally Advanced or Metastatic), run by Eddingpharm (Zhuhai) Co., Ltd..
Trial summary
This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic)
- What is being tested?
- GB268, Nab-Paclitaxel and Datopotamab Deruxtecan (Dato-DXd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2030
- 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
- Age ≥ 18 years, male or female.
- Histologically confirmed locally advanced unresectable or metastatic breast cancer (Triple-Negative Breast Cancer [TNBC] or Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative [HR+/HER2-]).
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1].
- No prior treatment with any immune checkpoint inhibitor (e.g., anti-Programmed Death-1 [PD-1], anti-Programmed Death-Ligand 1 [PD-L1], anti-Cytotoxic T-Lymphocyte-Associated Protein 4 [CTLA-4]) or Programmed Death-1/Vascular Endothelial Growth Factor [PD-1/VEGF] bispecific antibody, except for adjuvant therapy if relapse occurred ≥12 months after discontinuation.
- Assessed by the investigator as suitable for the assigned combination therapy.
- Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1.
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- Life expectancy ≥ 3 months.
- Adequate organ function (within 14 days before first dose, without transfusion or Granulocyte Colony-Stimulating Factor [G-CSF] support): Hemoglobin ≥ 9 g/dL, Absolute Neutrophil Count [ANC] ≥ 1.5×10^9/L, Platelets ≥ 100×10^9/L; Aspartate Aminotransferase [AST] and Alanine Aminotransferase [ALT] ≤ 3×Upper Limit of Normal [ULN] (≤5×ULN if liver metastases); Alkaline Phosphatase [ALP] ≤ 2.5×ULN (≤5×ULN if bone or liver metastases); Total Bilirubin ≤ 1.5×ULN (≤3×ULN for Gilbert's Syndrome); Serum Creatinine ≤ 1.5×ULN or Creatinine Clearance ≥ 50 mL/min (Cockcroft-Gault formula); Urine protein dipstick ≤ 1+ (if ≥2+, 24-hour urine protein quantification < 1 g); Coagulation function: International Normalized Ratio [INR] or activated Partial Thromboplastin Time [aPTT] ≤ 1.5×ULN (for patients not on anticoagulation therapy).
- Provide a Formalin-Fixed Paraffin-Embedded [FFPE] tumor tissue sample for biomarker testing.
- Effective contraception for fertile participants.
Who cannot join
- Prior anti-cancer therapy within specified washout periods.
- Systemic immunosuppressive therapy within 2 weeks before first dose.
- Major surgery or significant traumatic injury within 4 weeks before first dose.
- Unresolved toxicity from prior therapy > Grade 1 (except alopecia or Grade ≤2 hypothyroidism stable on hormone replacement).
- Prior immune-related adverse events [irAEs] ≥ Grade 3 leading to treatment discontinuation.
- Active Central Nervous System [CNS] metastases (except stable asymptomatic lesions).
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- History of other malignancies within 3 years (except cured non-melanoma skin cancer or carcinoma in situ).
- Uncontrolled pleural effusion or ascites requiring repeated drainage.
- Clinically significant cardiovascular disease (e.g., myocardial infarction, unstable angina, stroke within 6 months; QTcF prolongation; New York Heart Association [NYHA] Class II-IV heart failure; pericarditis/myocarditis).
- History of Interstitial Lung Disease [ILD] or non-infectious pneumonitis requiring steroids.
- Active or history of autoimmune disease requiring systemic treatment in the past 2 years.
- History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- History of hypertensive crisis or hypertensive encephalopathy.
- Severe coagulation disorders or significant bleeding risk (e.g., severe vascular disease, hemoptysis, intracranial/spinal hemorrhage, tumor invading major vessels).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
- Active infection requiring systemic anti-infective therapy within 2 weeks; severe infection within 4 weeks.
- Uncontrolled intercurrent illness (e.g., poorly controlled hypertension or Type 2 diabetes mellitus).
- Known active tuberculosis [TB].
- Positive for Hepatitis B Virus [HBV] surface antigen [HBsAg] or core antibody [HBcAb] with HBV-Deoxyribonucleic Acid [DNA] > 500 IU/mL; or positive Hepatitis C Virus [HCV] antibody with HCV-Ribonucleic Acid [RNA] above the lower limit of quantification.
- Known primary immunodeficiency or positive Human Immunodeficiency Virus [HIV] antibody.
- History of solid organ or hematopoietic stem cell transplantation (except corneal transplant).
- Pregnant or breastfeeding women.
- Known hypersensitivity to GB268 or its excipients; history of severe hypersensitivity to other monoclonal antibodies.
- Any other condition that would make the participant unsuitable for the study.
- History of severe hypersensitivity to other drugs in the combination regimen.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GB268 for Injection as Monotherapy or in Combination Regimens in Patients With Locally Advanced Unresectable or Metastatic Breast Cancer
This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.
Read the detailed description
The Phase Ib part of the study will primarily assess the safety and tolerability of GB268 in combination therapies, including dose-limiting toxicities (DLTs). The Phase II part will primarily evaluate the preliminary anti-tumor activity of GB268 as monotherapy and in various combination regimens in corresponding breast cancer populations.
- Being tested
- GB268, Nab-Paclitaxel, Datopotamab Deruxtecan (Dato-DXd), Sacituzumab Tirumotecan
- Keywords
- GB268, Immunotherapy, PD-1, CTLA-4, VEGF
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB268Drug
GB268 is a tri-specific antibody targeting PD-1, CTLA-4, and VEGF. It is designed to block immune checkpoints (PD-1/CTLA-4) to enhance T-cell-mediated anti-tumor immune responses and simultaneously inhibit VEGF-mediated tumor angiogenesis
Nab-PaclitaxelDrug
Nab-Paclitaxel is a microtubule-stabilizing agent formulated as albumin-bound nanoparticles for IV administration.
Datopotamab Deruxtecan (Dato-DXd)Drug
Datopotamab Deruxtecan is an ADC targeting Trop-2, consisting of a monoclonal antibody linked to a topoisomerase I inhibitor payload.
Sacituzumab TirumotecanDrug
A Trop-2-directed Antibody-Drug Conjugate [ADC] consisting of a humanized anti-Trop-2 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (GB268 + Sacituzumab Tirumotecan) | Experimental | GB268 (10 or 20 mg/kg Q3W intravenously [IV], dose selected by Safety Review Committee [SRC]) + Sacituzumab Tirumotecan 5 mg/kg once every 2 weeks [Q2W] IV. For participants with locally advanced/metastatic Triple-Negative Breast Cancer [TNBC] with no prior systemic therapy for advanced disease; no prior Trop-2 Antibody-Drug Conjugate [ADC]. Receives: Drug: GB268; Drug: Sacituzumab Tirumotecan |
| Cohort B (GB268 + Nab-Paclitaxel) | Experimental | GB268 (10 or 20 mg/kg Q3W IV) + Nab-Paclitaxel 260 mg/m² Day 1 Q3W IV. For participants with locally advanced/metastatic TNBC with no prior systemic therapy for advanced disease; prior adjuvant/neoadjuvant taxane allowed only if recurrence ≥12 months after last taxane dose. Receives: Drug: GB268; Drug: Nab-Paclitaxel |
| Cohort E (GB268+ Datopotamab Deruxtecan) | Experimental | GB268 (10 or 20 mg/kg Q3W IV) + Datopotamab Deruxtecan 6 mg/kg Day 1 Q3W IV. For participants with HR+/HER2- breast cancer who have received at least 1 line of endocrine therapy, CDK4/6i, and at least 1 line of systemic chemotherapy in the advanced setting; no prior Trop-2 ADC. Receives: Drug: GB268; Drug: Datopotamab Deruxtecan (Dato-DXd) |
| Cohort F (GB268 + Nab-Paclitaxel) | Experimental | GB268 (10 or 20 mg/kg Q3W IV) + Nab-Paclitaxel 260 mg/m² Day 1 Q3W IV. For participants with HR+/HER2- breast cancer with disease progression after ≥1 line of endocrine therapy and CDK4/6i, with primary or secondary endocrine resistance; prior adjuvant/neoadjuvant taxane allowed only if recurrence ≥12 months after last taxane dose. Receives: Drug: GB268; Drug: Nab-Paclitaxel |
| Cohort G (GB268 monotherapy) | Experimental | GB268 monotherapy (dose not exceeding 30 mg/kg Q3W, selected by SRC) IV. For participants with HR+/HER2- breast cancer who have received prior CDK4/6i and endocrine therapy in any setting, and a TROP2 or HER2 ADC in the advanced setting. Receives: Drug: GB268 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities [DLTs] (Phase Ib)
Incidence of Dose-Limiting Toxicities [DLTs] during the first treatment cycle
Measured: Within 21 days after first dose
Objective Response Rate [ORR] (Phase II)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Investigator per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]
Measured: Up to approximately 2 years
Secondary outcomes (10)
Number of participants with adverse events [AEs] (Phase Ib and Phase II)
Safety as assessed by clinical laboratory tests, 12-lead electrocardiogram (ECG), vital signs measurements, and the incidence, nature and severity of all adverse events (AEs) and serious AEs (SAEs)
Measured: Up to approximately 2 years
Objective Response Rate [ORR] (Phase Ib)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Measured: Up to approximately 2 years
Duration of Response [DOR] (Phase Ib and Phase II)
DOR assessed according to RECIST v1.1
Measured: Up to approximately 2 years
Overall Survival [OS] (Phase Ib and Phase II)
OS defined as the time from the first dose to death from any cause
Measured: Up to approximately 2 years
Disease Control Rate [DCR] (Phase Ib and Phase II)
DCR assessed according to RECIST v1.1
Measured: Up to approximately 2 years
Progression-Free Survival [PFS] (Phase Ib and Phase II)
PFS assessed according to RECIST v1.1
Measured: Up to approximately 2 years
Cmax of GB268 of GB268 (Phase Ib and Phase II)
Peak plasma concentration
Measured: Up to approximately 2 years
Tmax of GB268 (Phase Ib and Phase II)
Time to peak drug concentration
Measured: Up to approximately 2 years
AUC of GB268 (Phase Ib and Phase II)
Area under curve
Measured: Up to approximately 2 years
Number and percentage of participants with Anti-Drug Antibodies [ADAs] (Phase Ib and Phase II)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eddingpharm (Zhuhai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738341
- Sponsor's protocol ID
- GB268-201
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GB268 for Injection as Monotherapy or in Combination Regimens in Patients With Locally Advanced Unresectable or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07738341
- Acronym / sponsor ID
- GB268-201
- Keywords
- GB268, Immunotherapy, PD-1, CTLA-4, VEGF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Eddingpharm (Zhuhai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 31 Jul 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 is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.
Detailed description
The Phase Ib part of the study will primarily assess the safety and tolerability of GB268 in combination therapies, including dose-limiting toxicities (DLTs). The Phase II part will primarily evaluate the preliminary anti-tumor activity of GB268 as monotherapy and in various combination regimens in corresponding breast cancer populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A (GB268 + Sacituzumab Tirumotecan) | Experimental | Drug: GB268, Drug: Sacituzumab TirumotecanGB268 (10 or 20 mg/kg Q3W intravenously [IV], dose selected by Safety Review Committee [SRC]) + Sacituzumab Tirumotecan 5 mg/kg once every 2 weeks [Q2W] IV. For participants with locally advanced/metastatic Triple-Negative Breast Cancer [TNBC] with no prior systemic therapy for advanced disease; no prior Trop-2 Antibody-Drug Conjugate [ADC]. |
| Cohort B (GB268 + Nab-Paclitaxel) | Experimental | Drug: GB268, Drug: Nab-PaclitaxelGB268 (10 or 20 mg/kg Q3W IV) + Nab-Paclitaxel 260 mg/m² Day 1 Q3W IV. For participants with locally advanced/metastatic TNBC with no prior systemic therapy for advanced disease; prior adjuvant/neoadjuvant taxane allowed only if recurrence ≥12 months after last taxane dose. |
| Cohort E (GB268+ Datopotamab Deruxtecan) | Experimental | Drug: GB268, Drug: Datopotamab Deruxtecan (Dato-DXd)GB268 (10 or 20 mg/kg Q3W IV) + Datopotamab Deruxtecan 6 mg/kg Day 1 Q3W IV. For participants with HR+/HER2- breast cancer who have received at least 1 line of endocrine therapy, CDK4/6i, and at least 1 line of systemic chemotherapy in the advanced setting; no prior Trop-2 ADC. |
| Cohort F (GB268 + Nab-Paclitaxel) | Experimental | Drug: GB268, Drug: Nab-PaclitaxelGB268 (10 or 20 mg/kg Q3W IV) + Nab-Paclitaxel 260 mg/m² Day 1 Q3W IV. For participants with HR+/HER2- breast cancer with disease progression after ≥1 line of endocrine therapy and CDK4/6i, with primary or secondary endocrine resistance; prior adjuvant/neoadjuvant taxane allowed only if recurrence ≥12 months after last taxane dose. |
| Cohort G (GB268 monotherapy) | Experimental | Drug: GB268GB268 monotherapy (dose not exceeding 30 mg/kg Q3W, selected by SRC) IV. For participants with HR+/HER2- breast cancer who have received prior CDK4/6i and endocrine therapy in any setting, and a TROP2 or HER2 ADC in the advanced setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, male or female.
- Histologically confirmed locally advanced unresectable or metastatic breast cancer (Triple-Negative Breast Cancer [TNBC] or Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative [HR+/HER2-]).
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1].
- No prior treatment with any immune checkpoint inhibitor (e.g., anti-Programmed Death-1 [PD-1], anti-Programmed Death-Ligand 1 [PD-L1], anti-Cytotoxic T-Lymphocyte-Associated Protein 4 [CTLA-4]) or Programmed Death-1/Vascular Endothelial Growth Factor [PD-1/VEGF] bispecific antibody, except for adjuvant therapy if relapse occurred ≥12 months after discontinuation.
- Assessed by the investigator as suitable for the assigned combination therapy.
Key exclusion criteria (25 listed)
- Prior anti-cancer therapy within specified washout periods.
- Systemic immunosuppressive therapy within 2 weeks before first dose.
- Major surgery or significant traumatic injury within 4 weeks before first dose.
- Unresolved toxicity from prior therapy > Grade 1 (except alopecia or Grade ≤2 hypothyroidism stable on hormone replacement).
- Prior immune-related adverse events [irAEs] ≥ Grade 3 leading to treatment discontinuation.
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 |
|---|---|---|
| GB268GB268 is a tri-specific antibody targeting PD-1, CTLA-4, and VEGF. It is designed to block immune checkpoints (PD-1/CTLA-4) to enhance T-cell-mediated anti-tumor immune responses and simultaneously inhibit VEGF-mediated tumor angiogenesis | Drug | Cohort A (GB268 + Sacituzumab Tirumotecan), Cohort B (GB268 + Nab-Paclitaxel), Cohort E (GB268+ Datopotamab Deruxtecan), Cohort F (GB268 + Nab-Paclitaxel), Cohort G (GB268 monotherapy) |
| Nab-PaclitaxelNab-Paclitaxel is a microtubule-stabilizing agent formulated as albumin-bound nanoparticles for IV administration. | Drug | Cohort B (GB268 + Nab-Paclitaxel), Cohort F (GB268 + Nab-Paclitaxel) |
| Datopotamab Deruxtecan (Dato-DXd)Datopotamab Deruxtecan is an ADC targeting Trop-2, consisting of a monoclonal antibody linked to a topoisomerase I inhibitor payload. | Drug | Cohort E (GB268+ Datopotamab Deruxtecan) |
| Sacituzumab TirumotecanA Trop-2-directed Antibody-Drug Conjugate [ADC] consisting of a humanized anti-Trop-2 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload. | Drug | Cohort A (GB268 + Sacituzumab Tirumotecan) |
Primary outcome
Dose-Limiting Toxicities [DLTs] (Phase Ib)
Time frame: Within 21 days after first dose
Incidence of Dose-Limiting Toxicities [DLTs] during the first treatment cycle
Objective Response Rate [ORR] (Phase II)
Time frame: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Investigator per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]
10 secondary outcomes
Number of participants with adverse events [AEs] (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Objective Response Rate [ORR] (Phase Ib)
Time frame: Up to approximately 2 years
Duration of Response [DOR] (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Overall Survival [OS] (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Disease Control Rate [DCR] (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Progression-Free Survival [PFS] (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Cmax of GB268 of GB268 (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Tmax of GB268 (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
AUC of GB268 (Phase Ib and Phase II)
Time frame: Up to approximately 2 years
Number and percentage of participants with Anti-Drug Antibodies [ADAs] (Phase Ib and Phase II)
Time frame: Up to approximately 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 31 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GB268, Nab-Paclitaxel and Datopotamab Deruxtecan (Dato-DXd) in people with Breast Cancer (Locally Advanced or Metastatic), run by Eddingpharm (Zhuhai) 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 25 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 31 Jul 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?
Contact Binghe Xu (86 10 67781331, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities [DLTs] (Phase Ib) (time frame: Within 21 days after first dose). 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 31 Jul 2026.