Solid Tumor MalignancyPhase 1NCT06985368
A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
A Phase 1 study testing SIBP-A18 in people with Solid Tumor Malignancy, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Malignancy
- What is being tested?
- SIBP-A18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 15 Sep 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
- 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 advanced solid tumor diagnosed by histology and/or cytology, who have previously failed standard treatment, lack standard treatment regimens, are intolerant to standard treatment, or are currently not eligible for standard treatment.
- Indications expansion stage:
- Queue 1: CLDN18.2 positive late stage gastric cancer/gastroesophageal junction cancer (GC/GEJC) confirmed by histology or cytology with standard treatment failure, intolerance, or no standard treatment.
- Queue 2: Late stage CLDN18.2 positive PC confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.
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- Queue 3: CLDN18.2 positive late biliary tract cancer (BTC) confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.
- At least one measurable lesion must be selected as the target lesion (according to Response Evaluation Criteria In Solid Tumors (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 received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates
- 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:
Show all 28Show fewer
- 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 hepatitis B virus (HBV) and hepatitis C virus (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
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality
Jing Huang, 86-13301056087, huangjingwg@163.com
About this study
Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors
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-A18 in patients with advanced solid tumors.
This study is divided into three stages and is planned to be set up eight dose groups, including 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 milligram per kilogram (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. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and 6-9 participants will be enrolled in each dose group for dose expansion. The third stage is the indication expansion stage, where 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
- Solid Tumor Malignancy
- Being tested
- SIBP-A18
- Keywords
- Solid Tumor Malignancy, ADC, Safety, Efficacy, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A18Drug
SIBP-A18 formulation for injection, Claudin18.2-ADC. Strength: 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 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, 1mg/kg and 2mg/ kg were subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one participant. If dose-limiting toxicity (DLT) occurred, the traditional "3+3" dose escalation method was immediately switched. If DLT does not occur, the next dose group will be explored. The third stage will use RP2D for further exploration.
| Study group | Role | What they receive |
|---|---|---|
| SIBP-A18 | Experimental | The participants enrolled will be sequentially assigned to the corresponding dose level. Receives: Drug: SIBP-A18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
That is adverse events, any adverse events that occurred to the participant during the study period.
Measured: From day 1 after the first dose to day 28 after the last dose
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: From day 1 after the first dose to day 28 after the last dose
Area Under The Plasma Concentration Versus Time Curve (AUC)
It shows the degree to which a drug is absorbed and used in the body.
Measured: Day 1, Day 22 and Day 63 after the first dose
Peak Plasma Concentration (Cmax)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: Day 1, Day 22 and Day 63 after the first dose
Peak Time (Tmax)
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: Day 1, Day 22 and Day 63 after the first dose
Terminal elimination half-life (T ½ )
It reflects how quickly the drug is eliminated from the body.
Measured: Day 1, Day 22 and Day 63 after the first dose
Clearance Rate (CL)
Apparent volume of drug distribution removed from the body per unit time.
Measured: Day 1, Day 22 and Day 63 after the first dose
Secondary outcomes (4)
Objective Response Rate (ORR)
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: 6 weeks after the last evaluation
Disease control rate (DCR)
In clinical trials, the percentage of participants with advanced cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Measured: 6 weeks after the last evaluation
Progression-free survival (PFS)
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
overall survival (OS)
From randomization to time of death due to any cause.
Measured: 6 weeks after the last evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start16 Jun 2025
- Primary completion15 May 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignancyStudies 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, Docter, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985368
- Sponsor's protocol ID
- SIBP-A18-I
- Status last verified
- Jan 2026
- First submitted
- 14 May 2025
- 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 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT06985368
- Acronym / sponsor ID
- SIBP-A18-I
- Conditions
- Solid Tumor Malignancy
- Keywords
- Solid Tumor Malignancy, ADC, Safety, Efficacy, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 22 May 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.
The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors
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-A18 in patients with advanced solid tumors.
This study is divided into three stages and is planned to be set up eight dose groups, including 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 milligram per kilogram (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. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and 6-9 participants will be enrolled in each dose group for dose expansion. The third stage is the indication expansion stage, where 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-A18 | Experimental | Drug: SIBP-A18The participants 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 (17 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:
- Queue 1: CLDN18.2 positive late stage gastric cancer/gastroesophageal junction cancer (GC/GEJC) confirmed by histology or cytology with standard treatment failure, intolerance, or no standard treatment.
- Queue 2: Late stage CLDN18.2 positive PC confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.
- Queue 3: CLDN18.2 positive late biliary tract cancer (BTC) confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.
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:
- 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.
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-A18SIBP-A18 formulation for injection, Claudin18.2-ADC. Strength: 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 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, 1mg/kg and 2mg/ kg were subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one participant. If dose-limiting toxicity (DLT) occurred, the traditional "3+3" dose escalation method was immediately switched. If DLT does not occur, the next dose group will be explored. The third stage will use RP2D for further exploration. | Drug | SIBP-A18 |
Primary outcome
Adverse Events (AE)
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 participant during the study period.
Serious Adverse Events (SAE)
Time frame: From day 1 after the first dose to day 28 after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Area Under The Plasma Concentration Versus Time Curve (AUC)
Time frame: Day 1, Day 22 and Day 63 after the first dose
It shows the degree to which a drug is absorbed and used in the body.
Peak Plasma Concentration (Cmax)
Time frame: Day 1, Day 22 and Day 63 after the first dose
It shows the highest plasma concentration of a drug that can be achieved after administration.
Peak Time (Tmax)
Time frame: Day 1, Day 22 and Day 63 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.
Terminal elimination half-life (T ½ )
Time frame: Day 1, Day 22 and Day 63 after the first dose
It reflects how quickly the drug is eliminated from the body.
Clearance Rate (CL)
Time frame: Day 1, Day 22 and Day 63 after the first dose
Apparent volume of drug distribution removed from the body per unit time.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 weeks after the last evaluation
Disease control rate (DCR)
Time frame: 6 weeks after the last evaluation
Progression-free survival (PFS)
Time frame: 6 weeks after the last evaluation
overall survival (OS)
Time frame: 6 weeks after the last evaluation
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.
Jing Huang, Docter principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
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-A18 in people with Solid Tumor Malignancy, 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 17 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?
Adverse Events (AE) (time frame: From day 1 after the first dose to day 28 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.