A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.

NCT07205198 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-A10-I
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Conditions

Advanced Tumors

Keywords

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

Outcome Measures

Primary Outcomes (4)

• AE (Adverse Events)

  That is adverse events, any adverse events that occurred to the subject during the study period.

  From day 1 after the first dose to day 28 after the last dose

• Phase II recommended dose (RP2D)

  RP2D refers to the recommended dose determined through initial dose escalation and toxicity assessment in clinical trials, used for further evaluation of drug efficacy and safety.

  Day 21 after the last dose in the dose expansion phase

• Dose-limiting toxicity (DLT)

  DLT is defined as any adverse event related to the drug defined in the protocol that occurs within 21 days of the first cycle after a single administration.

  Day 21 after each dose in the dose escalation stage

• Maximum tolerated dose (MTD)

  MTD is defined as the maximum dose at which the number of DLT cases occurring during the DLT observation period within 21 days after a single administration is ≤ 1/6 of the total number of cases.

  Day 21 after the last dose in the dose escalation stage

Secondary Outcomes (7)

• AUC (Area Under The Plasma Concentration Versus Time Curve)

  Day 1, Day 22 and Day 64 after the first dose

• Cmax (Peak Plasma Concentration)

  Day 1, Day 22 and Day 64 after the first dose

• Tmax (Peak Time)

  Day 1, Day 22 and Day 64 after the first dose

• ORR (Objective Response Rate)

  6 weeks after the last evaluation

• DCR (Disease control rate)

  6 weeks after the last evaluation

Study Arms (1)

Experimental group

EXPERIMENTAL

The subjects enrolled will be sequentially assigned to the corresponding dose level.

Drug: SIBP-A10

Interventions

SIBP-A10 DRUG

SIBP-A10 injection. Strength: 0.5, 1.5, 3, 5, 7, 10 and 15 mg/kg. Intravenous infusion administration, with a treatment cycle of every 21 days, administered once on the first day of each cycle. The dose escalation stage,0.5 mg/kg group was subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one subject. If unacceptable toxic reactions occurred, the traditional "3+3" dose escalation method was immediately switched. If unacceptable toxic reactions do not occur, the next dose group will be explored. The third stage will use RP2D for further exploration.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Dalian University

Dalian, Liaoning, China

RECRUITING

Study Officials

• Li Zhang, Docter

  Shanghai Institute Of Biological Products

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan dan Chen, Master

CONTACT

+862162800991; ddchen.sh@sinopharm.com

Bao Yuan Shang, Master

CONTACT

+862162800991

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is an open-label, dose escalation, dose expansion, and indication expansion study.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)