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New treatment option for Advanced Solid Tumor
Official title A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.
ClinicalTrials.gov ID: NCT06512116
What this study is testing
What is SIBP-A17?
SIBP-A17 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as Her2-ADC.
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-A17 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 of 18 to 75 years old (including boundary values), gender not limited.
- The clinical diagnosis of enrolled people should meet the following criteria:
- Dose escalation stage: Advanced solid tumor people confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant...
- Dose expansion stage:
- Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or...
You likely can't join if
- Patients with tumors as specified in the protocol
- Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the...
- Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
- Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or...
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage...
- The screening period is accompanied by severe, progressive, or uncontrolled diseases, and it has been assessed by the researchers that participation...
See the full eligibility criteria
- Age range of 18 to 75 years old (including boundary values), gender not limited.
- The clinical diagnosis of enrolled people should meet the following criteria:
- Dose escalation stage: Advanced solid tumor people confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.
- Dose expansion stage:
- Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or intolerance.
- Cohort 2: HER2 positive (IHC3+or IHC2+and FISH+) local advanced or metastatic digestive system tumors that fail or are not tolerated after standard treatment, including adenocarcinoma of stomach or gastroesophageal...
- Cohort 3: HER2 positive (IHC3+or IHC2+with FISH+) advanced gynecological tumors that have failed or are intolerant to standard treatment, including but not limited to cervical cancer, endometrial cancer, and ovarian...
- Cohort 4: Other advanced solid tumors with HER2 expression that failed or were intolerant after standard treatment were preferentially included but not limited to HER2 positive (IHC3+or IHC2+and FISH+) breast cancer (at...
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples (only applicable during dose expansion phase).
- There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 criteria, CT or MRI). Lesions that have received previous radiotherapy or other local treatments are not considered as target...
- The Eastern Cooperative Oncology Group (ECOG) score for physical fitness is 0 or Expected survival period ≥ 3 months.
- During the screening period, the main organ functions were basically normal [no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of...
- During the screening period, women of childbearing age with negative blood pregnancy test results and reproductive age people (including male people) who have no pregnancy plans during the trial period and within 6...
- Voluntarily participate in this study and sign the informed consent form.
- Patients with tumors as specified in the protocol
- Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.
- Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
- Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serosal fluid drainage within 4 weeks...
- The screening period is accompanied by severe, progressive, or uncontrolled diseases, and it has been assessed by the researchers that participation in the study would increase the risk for the people.
- History of interstitial lung disease/non infectious pneumonia in the past, currently suffering from interstitial lung disease/non infectious pneumonia, or suspected interstitial lung disease/non infectious pneumonia...
- people who have experienced severe infections within 4 weeks prior to their first medication. Active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first medication. people...
- Participants who have participated in any clinical trial as people within the first 3 months of enrollment (excluding people who have only participated in clinical trial screening and have not used the investigational...
- According to the judgment of the investigator, there are concomitant diseases (such as severe diabetes, thyroid disease, etc.) that seriously endanger the safety of the subject or affect the completion of the study.
- 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.
- Researchers believe that participants who are not suitable for enrollment.
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.