NCT07205198 A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.
| NCT ID | NCT07205198 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Institute Of Biological Products |
| Condition | Advanced Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2025-10-31 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
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.
Contact & Investigator
Li Zhang, Docter
PRINCIPAL INVESTIGATOR
Shanghai Institute Of Biological Products
Frequently Asked Questions
Who can join the NCT07205198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07205198 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07205198 currently recruiting?
Yes, NCT07205198 is actively recruiting participants. Contact the research team at ddchen.sh@sinopharm.com for enrollment information.
Where is the NCT07205198 trial being conducted?
This trial is being conducted at Dalian, China.
Who is sponsoring the NCT07205198 clinical trial?
NCT07205198 is sponsored by Shanghai Institute Of Biological Products. The principal investigator is Li Zhang, Docter at Shanghai Institute Of Biological Products. The trial plans to enroll 160 participants.