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New treatment option for Solid Tumor Malignancy
Official title A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
ClinicalTrials.gov ID: NCT06985368
What this study is testing
What is SIBP-A18?
SIBP-A18 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor malignancy.
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
- The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18.
- 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.
- The clinical diagnosis of enrolled participants should meet the following criteria:
- Dose escalation and dose expansion stage: Patients with advanced solid tumor diagnosed by histology and/or cytology, who have previously failed...
- Indications expansion stage: Queue 1: CLDN18.2 positive late stage gastric cancer/gastroesophageal junction cancer (GC/GEJC) confirmed by histology...
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.
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.
- The clinical diagnosis of enrolled participants should meet the following criteria:
- Dose escalation and dose expansion stage: Patients with advanced solid tumor diagnosed by histology and/or cytology, who have previously failed standard treatment, lack standard treatment regimens, are intolerant to...
- Indications expansion stage: Queue 1: CLDN18.2 positive late stage gastric cancer/gastroesophageal junction cancer (GC/GEJC) confirmed by histology or cytology with standard treatment failure, intolerance, or no...
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.
- At least one measurable lesion must be selected as the target lesion (according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for...
- The patient has not previously received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates
- 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...
- 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...
- Voluntarily participate in this study and sign an informed consent form.
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...
- 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.
- Screening period for syphilis spiral antibody positive individuals; Individuals with active hepatitis B virus (HBV) and hepatitis C virus (HCV) infections; Except those with stable hepatitis B (DNA titer below the lower...
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks...
- The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk...
- Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of...
- According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.
- Hypertension that cannot be controlled clinically.
- Diabetes with poor drug control.
- Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.
- Serious infections that occurred within 4 weeks prior to initiating research treatment.
- Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug.
- Pregnant and lactating women.
- Patients deemed unsuitable for inclusion by researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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. 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.