AzTrials
AzTrials

Advanced Solid TumorPhase 1/2NCT07512583

Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors

A Phase 1/2 study testing TQB2930 injection+TQB2102 for injection in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label, multi-cohort phase Ib/II clinical study to evaluate the efficacy and safety of TQB2930 in combination with TQB2102 in patients with HER2-expressing advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TQB2930 injection+TQB2102 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
3 sitesChina
Study dates
27 May 2026to 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

  • The subjects voluntarily joined this study, signed an informed consent form, and had good compliance;
  • Age between 18 and 75 years old (calculated based on the date of signing the informed consent form);
  • Eastern Cooperative Oncology Group (ECOG) score from 0 to 1;
  • Expected survival is greater than 12 weeks;
  • Advanced solid tumors with HER2 expression confirmed by histopathological/cytological examination. HER2 expression includes HER2 positive (including Immunohistochemistry (IHC) 3+, IHC 2+and Fish positive), HER2 low expression (including IHC 1+ IHC 2+and Fish negative, HC 0 but with HER2 expression);
  • Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
Show all 16Show fewer
  • The laboratory inspection meets the following standards:
  • Blood routine: Hemoglobin (HGB) levels in the past 14 days without the use of growth factors or blood transfusions
  • 90g/L ； Neutrophil absolute value (NEUT) ≥ 1.5 × 10 9/L; Platelet count (PLT)
  • 100×10 9 /L ；
  • Liver function: For patients without liver metastasis, total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal (ULN), For patients with liver metastasis, total bilirubin (TBIL) ≤ 3.0 times the upper limit of normal (ULN); Alanine group Transferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If accompanied by liver transformation Move, then ALT and AST ≤ 5 × ULN;
  • Renal function: Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min (Using the standard Cockcroft Gault formula);
  • Urine routine test shows a urine protein concentration of ≤ 1+; If urinary protein is ≥ 2+, it needs to be tested for 24 hours within 7 days Urine protein quantitative testing can only be selected when the 24-hour urine protein is less than 1g;
  • Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT) International Normalized Ratio (INR) ≤ 1.5 × ULN;
  • Cardiac function: Left ventricular ejection fraction ≥ 50%;
  • Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study Shi had a negative serum pregnancy test within 7 days prior to enrollment in the study; Men should agree during and after the study period Effective avoidance measures must be taken within 6 months after completion.

Who cannot join

  • Patients with known spinal cord compression or active central nervous system metastasis (defined as untreated or symptomatic metastasis, or requiring corticosteroids or anticonvulsants to control related symptoms) are excluded, unless they have been stable for at least 4 weeks after treatment (no new or expanding imaging evidence of brain metastasis) and have not used corticosteroids and anticonvulsants within 2 weeks before randomization.
  • Subjects with only cutaneous and/or intracranial lesions as target lesions.
  • Concurrent diseases and medical history:
  • Have had or currently have other malignant tumors within 5 years, except for the following conditions: cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)], differentiated thyroid cancer, and colorectal intra-mucosal cancer;
  • The adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events Version (CTCAEv5.0) score of ≤1, except for Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which the investigator deems to pose
  • Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (excluding surgeries specified in the protocol) within 4 weeks before the first dose, or have long-term unhealed wounds or fractures (excluding pathological fractures, but if there is severe bone damage in bone metastases and it may affect survival, it needs to be excluded). (Major surgery is defined as surgeries at or above level 3 in the National Surgical Classification Catalogue 2022 edition);
Show all 40Show fewer
  • There are diseases that affect intravenous injection and venous blood sampling;
  • Subjects with congenital bleeding or coagulation dysfunction, or those who have experienced bleeding or coagulopathy within 28 days prior to the commencement of study treatment, or who have taken aspirin >325 mg/day (the maximum antiplatelet dose) within 7 days prior to the commencement of study treatment;
  • Cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, except for asymptomatic and non-treatment-required lacunar cerebral infarction) or pulmonary embolism occurred within 6 months before the first dose; currently, there is deep venous thrombosis requiring therapeutic intervention;
  • Poor blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
  • Suffering from major cardiovascular diseases, including any of the following conditions:
  • Cardiac insufficiency at or above New York Heart Association (NYHA) class II;
  • History of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, and torsade de pointes) or frequent and uncontrollable arrhythmias;
  • Unstable angina pectoris, or severe stenosis and occlusion of the coronary artery;
  • Suffered from myocardial infarction within 6 months;
  • The Fridericia-corrected QT interval (QTcF) is greater than 450 milliseconds (msec) for males and greater than 470 msec for females (if QTc is abnormal, it can be continuously measured three times with an interval of more than 2 minutes, and the average value can be taken);
  • History or family history of congenital long QT syndrome;
  • Presence of uncontrolled infection of ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 14 days prior to the commencement of study treatment;
  • Subjects with a history of interstitial lung disease/pneumonia (non-infectious) requiring steroid intervention, or currently accompanied by interstitial lung disease/pneumonia, or subjects with suspected interstitial lung disease/pneumonia indicated by imaging during the screening period and unable to be excluded;
  • Subjects with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obstructive bronchiolitis, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, etc.; subjects with active tuberculosis, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia during the screening period; and subjects with any autoimmune, connective tissue, or inflammatory diseases involving the lungs (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or those who have previously undergone unilateral pneumonectomy, etc.;
  • Subjects with active viral hepatitis and poor control. Subjects who meet the following requirements can be screened: HBsAg-positive subjects must meet the criteria of Hepatitis B Virus (HBV) DNA quantification <2000 IU/ml (or 1*104 copy/ml) or have received anti-HBV treatment for at least 1 week before the start of the study and have a 10-fold (1 log value) or greater reduction in viral index, and the subjects are willing to receive anti-HBV treatment throughout the entire study period; HCV-infected subjects (HCV Ab or HCV RNA positive): subjects who are judged by the investigator to be in a stable state or are currently undergoing antiviral treatment at the time of enrollment and continue to receive approved antiviral treatment during the study;
  • Individuals with active syphilis infection requiring treatment;
  • Those who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
  • Subjects who require immunosuppressive agents, systemic or absorbable local hormone therapy for immunosuppression, and still need to continue using them within 7 days before the first administration (excluding subjects with a daily dose of <10 mg prednisone or other equally effective hormones);
  • History of immune deficiency, including HIV positivity or other acquired or congenital immune deficiency diseases;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis; or those who have previously had or currently have nephrotic syndrome (excluding those who have been cured) or chronic nephritis;
  • Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L);
  • Those who suffer from epilepsy and require treatment;
  • Individuals with a history of abuse of psychotropic drugs and unable to quit, or those with severe mental disorders.
  • Tumor-related symptoms and treatment:
  • There has been moderate to large amounts of pleural effusion, ascites, and pericardial effusion in the past 2 weeks;
  • Patients with cancerous lymphangitis;
  • Tumor invasion of major blood vessels;
  • Patients who have received intravenous chemotherapy, radiotherapy, immunotherapy, biotherapy, or macromolecular targeted therapy for anti-tumor treatment within 3 weeks before the start of the study treatment, or who have received endocrine therapy, small molecule targeted drugs, or oral chemotherapy within 2 weeks before the start of the study treatment, the washout period is calculated from the end of the last treatment;
  • Patients who have received treatment with traditional Chinese patent medicines and simple preparations (including but not limited to Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea javanica oil injection/capsules, Xiaocaiping Tablets/Injection, Huachansu Capsules, etc.) with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) -approved drug instructions within 2 weeks before the start of the study treatment.
  • Research treatment-related
  • Previously received ADC therapy using a topoisomerase 1 inhibitor as the toxin during the recurrence or metastasis stage, or experienced recurrence or metastasis within 12 months after neoadjuvant/adjuvant therapy (excluding cohort 5 in the extension stage);
  • Allergic to any research drug or any ingredient or adjuvant in the drug; 39. 3) Individuals who have experienced severe hypersensitivity reactions after the use of monoclonal antibodies;
  • Subjects who have received treatment with other anti-tumor drugs in clinical trials within 4 weeks prior to the start of the study treatment, if the clinical study involves a marketed drug, shall be excluded according to exclusion criterion 4.2).
  • According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Binghe Xu, Doctor contact

13501028690

xubinghe@medmail.com.cn

China3 sites, 3 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binghe Xu, Doctor, 13501028690, xubinghe@medmail.com.cn

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Wenhui Zhao, Doctor, 18745177632, zhaowenhui1977@163.com

    Guangyu Wang, Doctor, 18249038966, wangguangyu03@163.com

    Not yet recruiting

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality, 300060

    Yehui Shi, Doctor, 13602088477, carfield@medmail.com.cn

    Not yet recruiting

Other trials in China

About this study

Official title: Phase Ib/II Clinical Trial of TQB2930 Injection in Combination With TQB2102 for Injection in Patients With HER2-Expressing Advanced Solid Tumors

This is a multicenter, open-label, multi-cohort phase Ib/II clinical study to evaluate the efficacy and safety of TQB2930 in combination with TQB2102 in patients with HER2-expressing advanced solid tumors.

Being tested
TQB2930 injection+TQB2102 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2930 injection+TQB2102 for injectionDrug

    TQB2930 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody.

    TQB2102 for injection is a HER2 - targeted dual epitope Antibody-Drug Conjugate (ADC).

Study groups in NCT07512583
Study groupRoleWhat they receive
TQB2930 injection+TQB2102 for injectionExperimentalTQB2930 injection: Intravenous infusion, administered once on Day 1 of each treatment cycle, 21 days as a treatment cycle. TQB2102 for injection: Intravenous infusion, administered once on day 1 of each treatment cycle, 21 days as a treatment cycle.
Receives: Drug: TQB2930 injection+TQB2102 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose

    Recommended Phase 2 Dose

    Measured: From first dose to 21days after first dose

  2. Overall response rate (ORR)

    After enrollment of all patients, the proportion of participants with the best overall efficacy rated as complete response or partial response according to criteria (RECIST1.1).

    Measured: The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient

Secondary outcomes (12)

  1. Progression-free survival (PFS)

    Defined as the time from first dose to first occurrence of disease progression or death due to any cause.

    Measured: The estimated time from randomization to patient disease progression was 10 months

  2. Duration of response (DOR)

    Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.

    Measured: The estimated duration was 27 months from enrollment of the first patient to 10 months after enrollment of the last patient

  3. Disease control rate (DCR)

    Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients..

    Measured: The estimated duration was 27 months from enrollment of the first patient to 10 months after enrollment of the last patient

  4. Overall survival (OS)

    The time from enrollment to death due to any cause.

    Measured: From enrollment until patient death, it is expected to be evaluated up to 5 years

  5. Number of patients with adverse events (AEs) and serious adverse events (SAEs)

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Baseline up to 30 days after the last dose

  6. AE/SAE severity

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Baseline up to 30 days after the last dose

  7. Complete response rate

    The proportion of patients who have achieved complete remission.

    Measured: The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient

  8. Cmax

    The highest blood concentration that occurs after administration.

    Measured: 60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle)

  9. clearance rate (CL)

    The number of apparent volumes of distribution of the drug cleared from the body per unit of time.

    Measured: 60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle)

  10. T1/2

    The time it takes for the concentration of the drug to drop by half.

    Measured: 60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle)

  11. Vz

    The ratio constant of the amount of drug in the body to the concentration of the drug in the blood when the drug reaches homeostasis in the body.

    Measured: 60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle)

  12. Area under the blood drug concentration time curve

    The area covered by the concentration curve of drugs in the blood over time

    Measured: 60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start27 May 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07512583
Sponsor's protocol ID
TQB2930-TQB2102-Ib/II-01
Status last verified
Oct 2025
First submitted
25 Mar 2026
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB2930 injection+TQB2102 for injection in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. 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 16 inclusion and 40 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 8 Jun 2026. 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 Binghe Xu, Doctor (13501028690, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (time frame: From first dose to 21days 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?

On the ClinicalTrials.gov record for NCT07512583.

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 8 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in