Advanced Solid TumorPhase 1NCT06298058
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
A Phase 1 study testing SIBP-A13 formulation for injection in people with Advanced Solid Tumor, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 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 Solid Tumor
- What is being tested?
- SIBP-A13 formulation for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2024to 30 Jun 2026
- 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
- Age range from 18 to 75 years old (including boundary values), regardless of gender.
- The clinical diagnosis of enrolled participants should meet the following criteria:
- Dose escalation and dose expansion stage: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology and judged by the researcher to be unable to benefit from available standard treatment, or intolerant.
- Indications expansion stage:
- Queue 1: Non-small cell lung cancer (NSCLC) confirmed by histology or cytology, with disease progression and EGFR mutation during or after treatment with third generation TKI and platinum containing therapy.
- Queue 2: Breast cancer (BC) confirmed as HER3 positive by histology or cytology after standard treatment failure.
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- Queue 3: Patients with recurrent/metastatic advanced HNSCC confirmed by histology or cytology, unsuitable for radical surgical resection, and standard treatment failure.
- At least one measurable lesion must be selected as the target lesion (according to RECIST v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).
- The patient has not previously used anti-HER3 antibodies or other HER3 targeted treatments (such as Deparezumab (HER3-DXd).
- Drugs that have not received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates (ADCs) .
- ECOG score 0-1.
- Expected survival time ≥ 3 months.
- During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug):
- Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9/L, platelet (PLT) count ≥ 90 × 10 9/L, hemoglobin (HGB) ≥ 90 g/L.
- Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Participants with the following tumors:
- The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).
- The participant has untreated imaging confirmed central nervous system metastasis.
- Meningeal metastases.
- Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.
- Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:
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- Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;
- Patients undergoing adjuvant therapy within 6 months after surgery;
- Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);
- Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs.
- Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients).
- The dose (prednisone>10 mg/d or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.
- Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:
- Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration.
- Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Screening period for syphilis spiral antibody positive individuals; Individuals with active HBV and HCV infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment.
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration.
- The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk. Including but not limited to:
- Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of cardiac or renal dysfunction ≥ Level II.
- According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.
- Hypertension that cannot be controlled clinically.
- Diabetes with poor drug control.
- Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.
- Serious infections that occurred within 4 weeks prior to initiating research treatment.
- Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug.
- Pregnant and lactating women.
- Patients deemed unsuitable for inclusion by researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Caicun Zhou, Doctor
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Read the detailed description
This study is an open, multi-dose increasing single and multiple doses increasing, dose expanding, and indication expanding study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, and explore potential biomarkers of SIBP-A13 in patients with advanced solid tumors.
This study is divided into three stages and is planned to be set up six dose groups, including 1, 2, 4, 5, 6, and 8 mg/kg. The first stage is the dose escalation stage, with a planned enrollment of 16-36 participants. The second stage is the dose expansion stage, where two doses are selected to enter the dose expansion phase. 6-9 late-stage solid tumor participants are enrolled in each dose group for dose expansion, and 12-18 participants are planned to be enrolled in the dose expansion phase. 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 three indication cohorts, with at least 30 participants selected for each cohort.
- Conditions
- Advanced Solid Tumor
- Being tested
- SIBP-A13 formulation for injection
- Keywords
- Advanced solid tumor, Her3-ADC, Safety, Efficacy, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A13 formulation for injectionDrug
Also called Her3-ADC
SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a "3+3" dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SIBP-A13 | Experimental | SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Receives: Drug: SIBP-A13 formulation for injection |
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 participant during the study period.
Measured: 28 days after the last dose
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: 28 days after the last dose
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: 18 weeks after the first dose
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: 18 weeks 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 participant plasma concentration curve after administration.
Measured: 18 weeks after the first dose
T ½ (Terminal elimination half-life)
It reflects how quickly the drug is eliminated from the body.
Measured: 18 weeks after the first dose
CL (Clearance Rate)
Apparent volume of drug distribution removed from the body per unit time.
Measured: 18 weeks after the first dose
Secondary outcomes (4)
ORR (Objective Response Rate)
The proportion of participants whose tumor volume shrinks to a predetermined value and maintains the minimum time limit and is the sum of complete and partial responses.
Measured: 7 days after the last dose
DCR (Disease control rate)
In clinical trials, the percentage of participants with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Measured: 7 days after the last dose
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: 7 days after the last dose
OS (overall survival)
From randomization to time of death due to any cause.
Measured: 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start9 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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, multi-dose increasing single and multiple dose study.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Doctor, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298058
- Sponsor's protocol ID
- SIBP-A13-I
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2024
- Last updated
- 7 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
- ClinicalTrials.gov ID
- NCT06298058
- Acronym / sponsor ID
- SIBP-A13-I
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced solid tumor, Her3-ADC, Safety, Efficacy, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Mar 2024 (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, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Detailed description
This study is an open, multi-dose increasing single and multiple doses increasing, dose expanding, and indication expanding study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, and explore potential biomarkers of SIBP-A13 in patients with advanced solid tumors.
This study is divided into three stages and is planned to be set up six dose groups, including 1, 2, 4, 5, 6, and 8 mg/kg. The first stage is the dose escalation stage, with a planned enrollment of 16-36 participants. The second stage is the dose expansion stage, where two doses are selected to enter the dose expansion phase. 6-9 late-stage solid tumor participants are enrolled in each dose group for dose expansion, and 12-18 participants are planned to be enrolled in the dose expansion phase. 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 three indication cohorts, with at least 30 participants 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, multi-dose increasing single and multiple dose study.
| Arm | Type | Receives |
|---|---|---|
| SIBP-A13 | Experimental | Drug: SIBP-A13 formulation for injectionSIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age range from 18 to 75 years old (including boundary values), regardless of gender.
- The clinical diagnosis of enrolled participants should meet the following criteria:
- At least one measurable lesion must be selected as the target lesion (according to RECIST v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).
- The patient has not previously used anti-HER3 antibodies or other HER3 targeted treatments (such as Deparezumab (HER3-DXd).
- Drugs that have not received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates (ADCs) .
Key exclusion criteria (28 listed)
- Participants with the following tumors:
- Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:
- Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:
- Screening period for syphilis spiral antibody positive individuals; Individuals with active HBV and HCV infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment.
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration.
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-A13 formulation for injectionAlso: Her3-ADCSIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a "3+3" dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks. | Drug | SIBP-A13 |
Primary outcome
AE (Adverse Events)
Time frame: 28 days after the last dose
That is adverse events, any adverse events that occurred to the participant during the study period.
SAE (Serious Adverse Events)
Time frame: 28 days after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
AUC (Area Under The Plasma Concentration Versus Time Curve)
Time frame: 18 weeks after the first dose
It shows the degree to which a drug is absorbed and used in the body.
Cmax (Peak Plasma Concentration)
Time frame: 18 weeks after the first dose
It shows the highest plasma concentration of a drug that can be achieved after administration.
Tmax (Peak Time)
Time frame: 18 weeks after the first dose
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
T ½ (Terminal elimination half-life)
Time frame: 18 weeks after the first dose
It reflects how quickly the drug is eliminated from the body.
CL (Clearance Rate)
Time frame: 18 weeks after the first dose
Apparent volume of drug distribution removed from the body per unit time.
4 secondary outcomes
ORR (Objective Response Rate)
Time frame: 7 days after the last dose
DCR (Disease control rate)
Time frame: 7 days after the last dose
PFS (Progression-free survival)
Time frame: 7 days after the last dose
OS (overall survival)
Time frame: 7 days after the last dose
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 7 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.
Caicun Zhou, Doctor principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
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-A13 formulation for injection in people with Advanced Solid Tumor, 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 16 inclusion and 28 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 7 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 Dandan Chen, Master (86-021-62800991, 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: 28 days after the last dose). The study lists 7 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 7 Jan 2026.