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New treatment option for Advanced Solid Tumors
Official title A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
ClinicalTrials.gov ID: NCT06990464
What this study is testing
What is SIBP-A19?
SIBP-A19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
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
- To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
- Phase 1: an early, usually small safety study
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
- Age range from 18 to 75 years old (including boundary values), regardless of gender.
- Voluntarily participate in this study and sign the informed consent form.
- Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or...
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that...
- There must be at least one measurable lesion as the target lesion.
You likely can't join if
- Participants with the following tumors:
- The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly...
- The participant has untreated imaging confirmed central nervous system metastasis.
- Meningeal metastases.
- Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been...
- Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial...
See the full eligibility criteria
Who can join
- Age range from 18 to 75 years old (including boundary values), regardless of gender.
- Voluntarily participate in this study and sign the informed consent form.
- Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance.
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements.
- There must be at least one measurable lesion as the target lesion.
- ECOG score 0-1.
- Expected survival time ≥ 3 months.
- During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14...
- Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9/L, platelet (PLT) count ≥ 90 × 10 9/L, hemoglobin (HGB) ≥ 90 g/L.
- Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective...
What rules you out
- Participants with the following tumors:
- The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin...
- The participant has untreated imaging confirmed central nervous system metastasis.
- Meningeal metastases.
- Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped...
- Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:
- Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;
- Patients undergoing adjuvant therapy within 6 months after surgery;
- Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);
- Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical...
- Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone...
- The dose (prednisone\>10 mg/d or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.
- Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:
- Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to...
- Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Known history of drug abuse, alcoholism, or drug use that may affect the results of the trial.
- According to the investigator's judgment, the screening period is accompanied by serious, progressive, or uncontrolled diseases, and the investigator's assessment determines that the participant's participation in the...
- According to the investigator's judgment, there are serious accompanying diseases that pose a threat to patient safety or affect the completion of the study.
- Patients with uncontrolled ascites, pleural effusion, pericardial effusion during the screening period or those who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first...
- Patients who must take supplements containing folic acid (such as those with folate deficiency).
- Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug.
- Pregnant and lactating women.
- Patients who are deemed unsuitable to participate in this clinical study due to other reasons by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, 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 Fuzhou, Fujian, 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.