SIBP-A10 injection for adults with advanced malignant tumors

A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects

This trial will test whether SIBP-A10 injections are safe and tolerable and to identify the best dose for adults with advanced metastatic tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Dalian, Liaoning)
• Trial ID: NCT07205198 on ClinicalTrials.gov

What this trial studies

This open-label phase 1 study uses dose escalation, dose expansion, and indication expansion stages to evaluate SIBP-A10 given by injection in adults with advanced metastatic tumors. Planned doses range from 0.5 to 15 mg/kg with an initial 3+3 escalation design, followed by selected dose expansions (about 20 subjects per expansion cohort) and four indication-specific expansion cohorts (about 40 subjects each) to define a phase II recommended dose. Key measures include safety, tolerability, pharmacokinetics, immunogenicity, impact on QT/QTc interval, preliminary anti-tumor activity, and exploratory biomarker analyses. Enrollment requires measurable disease, adequate organ function, ECOG 0–1, and willingness to provide tumor tissue.

Who should consider this trial

Good fit: Adults 18–75 with advanced or metastatic tumors, at least one measurable lesion, ECOG performance status 0–1, adequate organ function, expected survival ≥3 months, no prior Siglec-15–targeted therapy, and able to provide tumor tissue are ideal candidates.

Not a fit: Patients with poor organ function, ECOG >1, expected survival under three months, pregnancy or breastfeeding, or prior exposure to Siglec-15–targeted agents are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, SIBP-A10 could provide a new treatment option with a defined safe dose and potential anti-tumor activity for patients with advanced tumors.

How similar studies have performed: Targeting Siglec-15 is a relatively new immunotherapy approach with limited early clinical data and no established large-scale successes to date.

Eligibility criteria

Inclusion Criteria:

* Voluntarily participate in this study and sign an informed consent form;
* Age range of 18 to 75 years old (including boundary values), gender not limited;
* The clinical diagnosis of enrolled subjects should meet the conditions specified in the protocol:
* There must be at least one measurable lesion as the target lesion;
* Backfilling queue during dose escalation stage, dose expansion stage, and indication expansion stage: able to provide tumor tissue samples that meet the requirements of the protocol or undergo tumor biopsy during screening, or provide testing reports issued by legitimate testing institutions that meet the requirements;
* I have not received any medication targeting Siglec-15 in the past;
* The Eastern Cooperative Oncology Group (ECOG) physical fitness score ranges from 0 to 1;
* Expected survival period ≥ 3 months;
* During the screening period, the main organ functions were basically normal;
* During the screening period, women of childbearing age had negative blood pregnancy tests, and reproductive age subjects (including male subjects) had no pregnancy plans during the trial period and within 6 months after the last dose, and voluntarily took effective contraceptive measures.

Exclusion Criteria:

* The subject has the following tumors:

  * The subject has had other malignant tumors that have not healed within the past 5 years;
  * Subjects with meningeal metastases;
  * Subjects with active brain metastases;
* For anti-tumor subjects with a history of past treatment or surgery that does not comply with the protocol, or who have received treatment that does not comply with the protocol during the planned trial period
* Previous medical history or laboratory non-compliance with protocol requirements
* According to the researchers' assessment, the screening period is accompanied by severe, progressive, or uncontrolled non-tumor diseases, and it has been determined by the researchers that participating in the study would increase the risk for the subjects.
* According to the investigator's judgment, there are concomitant diseases (including but not limited to hypertension, diabetes, active infection, etc. that cannot be controlled by drugs) that seriously endanger the patient's safety or affect the patient's completion of the study
* Researchers determine that there are uncontrollable ascites, pleural effusion, or pericardial effusion, or those who have undergone ≥ 2 serosal drainage within 2 weeks prior to the first administration;
* Before starting treatment, the patient has not yet recovered to ≤ grade 1 from the toxic effects of previous treatments (including previous immunotherapy) and/or complications of previous surgical interventions.
* 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 subjects who are not suitable to participate in this clinical study due to other reasons.

Where this trial is running

Dalian, Liaoning

• Zhongshan Hospital Affiliated to Dalian University — Dalian, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang, Docter — Shanghai Institute Of Biological Products
• Study coordinator: Dan dan Chen, Master

Conditions Advanced Tumors; Advanced malignant tumor; SIBP-A10; safety; efficacy; pharmacokinetics