Advanced TumorsPhase 1NCT07205198
A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.
A Phase 1 study testing SIBP-A10 in people with Advanced Tumors, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- SIBP-A10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bao Yuan Shang, Master contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Dalian University
Dalian, Liaoning
Ruoyu Wang, 86-13942875869, wangruoyu@dlu.edu.cn
About this study
Official title: 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
To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Read the detailed description
This study is an open label, dose escalation, dose expansion, and indication expansion study to evaluate safety, tolerability, pharmacokinetics, preliminary anti-tumor efficacy, immunogenicity, impact on QT/QTc interval, and explore potential biomarkers of SIBP-A10 for injection in subjects with advanced metastatic tumors.
This study is divided into three stages and is planned to be set up seven dose groups, including 0.5, 1.5, 3, 5, 7, 10 and 15 mg/kg. The first stage is the dose escalation stage, which will start from the first and second doses for enrollment. If necessary, a 3+3 dose escalation design will be used. At least 19 subjects will be enrolled, and the specific sample size should be adjusted according to the subjects' tolerance level. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and at least 20 subjects will be enrolled in each dose group for dose expansion. The third stage is the indication expansion stage, where phase II recommended dose (RP2D) is preliminarily determined based on the escalation and expansion of dosage in the early stage. Using RP2D for indication expansion, we plan to expand four indication cohorts, with at least 40 subjects selected for each cohort.
- Conditions
- Advanced Tumors
- Being tested
- SIBP-A10
- Keywords
- Advanced malignant tumor, SIBP-A10, safety, efficacy, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A10Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The subjects enrolled will be sequentially assigned to the corresponding dose level. Receives: Drug: SIBP-A10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE (Adverse Events)
That is adverse events, any adverse events that occurred to the subject during the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21 after the last dose in the dose escalation stage
Secondary outcomes (7)
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Measured: Day 1, Day 22 and Day 64 after the first dose
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: Day 1, Day 22 and Day 64 after the first dose
Tmax (Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.
Measured: Day 1, Day 22 and Day 64 after the first dose
ORR (Objective Response Rate)
The proportion of subjects whose tumor volume shrinks to a predetermined value and maintains the minimum time limit and is the sum of complete and partial responses.
Measured: 6 weeks after the last evaluation
DCR (Disease control rate)
In clinical trials, the percentage of subjects with advanced cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Measured: 6 weeks after the last evaluation
PFS (Progression-free survival)
The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).
Measured: 6 weeks after the last evaluation
OS (overall survival)
From randomization to time of death due to any cause.
Measured: From the first injection to 36 months after the first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start31 Oct 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an open-label, dose escalation, dose expansion, and indication expansion study.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Docter, Principal investigator, Shanghai Institute Of Biological Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205198
- Sponsor's protocol ID
- SIBP-A10-I
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07205198
- Acronym / sponsor ID
- SIBP-A10-I
- Conditions
- Advanced Tumors
- Keywords
- Advanced malignant tumor, SIBP-A10, safety, efficacy, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Detailed description
This study is an open label, dose escalation, dose expansion, and indication expansion study to evaluate safety, tolerability, pharmacokinetics, preliminary anti-tumor efficacy, immunogenicity, impact on QT/QTc interval, and explore potential biomarkers of SIBP-A10 for injection in subjects with advanced metastatic tumors.
This study is divided into three stages and is planned to be set up seven dose groups, including 0.5, 1.5, 3, 5, 7, 10 and 15 mg/kg. The first stage is the dose escalation stage, which will start from the first and second doses for enrollment. If necessary, a 3+3 dose escalation design will be used. At least 19 subjects will be enrolled, and the specific sample size should be adjusted according to the subjects' tolerance level. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and at least 20 subjects will be enrolled in each dose group for dose expansion. The third stage is the indication expansion stage, where phase II recommended dose (RP2D) is preliminarily determined based on the escalation and expansion of dosage in the early stage. Using RP2D for indication expansion, we plan to expand four indication cohorts, with at least 40 subjects selected for each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an open-label, dose escalation, dose expansion, and indication expansion study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SIBP-A10The subjects enrolled will be sequentially assigned to the corresponding dose level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (13 listed)
- The subject has the following tumors:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIBP-A10SIBP-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. | Drug | Experimental group |
Primary outcome
AE (Adverse Events)
Time frame: From day 1 after the first dose to day 28 after the last dose
That is adverse events, any adverse events that occurred to the subject during the study period.
Phase II recommended dose (RP2D)
Time frame: Day 21 after the last dose in the dose expansion phase
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.
Dose-limiting toxicity (DLT)
Time frame: Day 21 after each dose in the dose escalation stage
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.
Maximum tolerated dose (MTD)
Time frame: Day 21 after the last dose in the dose escalation stage
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.
7 secondary outcomes
AUC (Area Under The Plasma Concentration Versus Time Curve)
Time frame: Day 1, Day 22 and Day 64 after the first dose
Cmax (Peak Plasma Concentration)
Time frame: Day 1, Day 22 and Day 64 after the first dose
Tmax (Peak Time)
Time frame: Day 1, Day 22 and Day 64 after the first dose
ORR (Objective Response Rate)
Time frame: 6 weeks after the last evaluation
DCR (Disease control rate)
Time frame: 6 weeks after the last evaluation
PFS (Progression-free survival)
Time frame: 6 weeks after the last evaluation
OS (overall survival)
Time frame: From the first injection to 36 months after the first injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bao Yuan Shang, Master contact
Li Zhang, Docter principal investigator
Shanghai Institute Of Biological Products
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIBP-A10 in people with Advanced Tumors, run by Shanghai Institute Of Biological Products at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan dan Chen, Master (+862162800991, ddchen.sh@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (Adverse Events) (time frame: From day 1 after the first dose to day 28 after the last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.