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New treatment option for Advanced Solid Tumor
Official title Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07512583
What this study is testing
What is TQB2930 injection+TQB2102 for injection?
TQB2930 injection+TQB2102 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people 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...
You likely can't join if
- Patients with known spinal cord compression or active central nervous system metastasis (defined as untreated or symptomatic metastasis, or requiring...
- people 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...
- The adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events Version (CTCAEv5.0) score of...
- Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment...
See the full eligibility criteria
Who can join
- The people 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...
- Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
- 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...
- 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...
- 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...
What rules you out
- 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...
- people 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...
- 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...
- 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...
- There are diseases that affect intravenous injection and venous blood sampling;
- people 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...
- Cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, except for asymptomatic and non-treatment-required lacunar cerebral infarction) or pulmonary embolism occurred...
- 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...
- 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;
- people with a history of interstitial lung disease/pneumonia (non-infectious) requiring steroid intervention, or currently accompanied by interstitial lung disease/pneumonia, or people with suspected interstitial lung...
- people 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...
- people with active viral hepatitis and poor control. people who meet the following requirements can be screened: HBsAg-positive people must meet the criteria of Hepatitis B Virus (HBV) DNA quantification \<2000 IU/ml...
- Individuals with active syphilis infection requiring treatment;
- Those who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
- people 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 people with...
- 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...
- 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...
- 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...
- 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;
- people 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...
- According to the researcher's judgment, there are situations that seriously endanger the safety of the people or affect their ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Harbin, Heilongjiang, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Harbin, Heilongjiang, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.