Treatment of advanced solid tumors with SIBP-A17 injection

An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of SIBP-A17 Formulation for Injection in Subjects With Advanced Solid Tumors.

This study is testing a new injection called SIBP-A17 to see if it can safely help people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06512116 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of SIBP-A17 in patients with advanced solid tumors. It consists of two stages: a dose escalation phase using a '3+3' design to determine the maximum tolerable dose, followed by a dose expansion phase to assess efficacy in specific tumor types. Participants will receive varying doses of SIBP-A17, and the study aims to gather data on its anti-tumor effects and potential biomarkers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors that have not responded to standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies using similar approaches in targeting advanced solid tumors have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Age range of 18 to 75 years old (including boundary values), gender not limited.
* The clinical diagnosis of enrolled subjects should meet the following criteria:

  1. Dose escalation stage:

     Advanced solid tumor subjects confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.
  2. 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 junction, colorectal cancer, etc. (pancreatic cancer and biliary tract cancer are excluded).
     * 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 cancer.
     * 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 least 10 cases included), non-small cell lung cancer, etc.
* 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 lesions unless there is clear progression of the lesion.
* 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 \[no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the experimental drug\]
* During the screening period, women of childbearing age with negative blood pregnancy test results and reproductive age subjects (including male subjects) who have no pregnancy plans during the trial period and within 6 months after the last dose and voluntarily take effective contraceptive measures.
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* 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 before the first administration.
* 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 subjects.
* 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 that cannot be excluded through imaging examination during screening.
* Subjects 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. Subjects receiving prophylactic antibiotic treatment can be enrolled.
* Participants who have participated in any clinical trial as subjects within the first 3 months of enrollment (excluding subjects who have only participated in clinical trial screening and have not used the investigational drug).
* 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.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jing Huang, Doctor — Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical
• Study coordinator: Dandan Chen, Master

Conditions Advanced Solid Tumor; Advanced solid tumor; Her2-ADC; Safety; Efficacy; Pharmacokinetics