Advanced Solid TumorPhase 1NCT06512116
A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.
A Phase 1 study testing SIBP-A17 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-A17 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-A17
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 30 Dec 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 of 18 to 75 years old (including boundary values), gender not limited.
- The clinical diagnosis of enrolled subjects should meet the following criteria:
- Dose escalation stage:
- Advanced solid tumor subjects confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.
- Dose expansion stage:
- Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or intolerance.
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- Cohort 2: HER2 positive (IHC3+or IHC2+and FISH+) local advanced or metastatic digestive system tumors that fail or are not tolerated after standard treatment, including adenocarcinoma of stomach or gastroesophageal junction, colorectal cancer, etc. (pancreatic cancer and biliary tract cancer are excluded).
- Cohort 3: HER2 positive (IHC3+or IHC2+with FISH+) advanced gynecological tumors that have failed or are intolerant to standard treatment, including but not limited to cervical cancer, endometrial cancer, and ovarian cancer.
- Cohort 4: Other advanced solid tumors with HER2 expression that failed or were intolerant after standard treatment were preferentially included but not limited to HER2 positive (IHC3+or IHC2+and FISH+) breast cancer (at least 10 cases included), non-small cell lung cancer, etc.
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples (only applicable during dose expansion phase).
- There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 criteria, CT or MRI). Lesions that have received previous radiotherapy or other local treatments are not considered as target lesions unless there is clear progression of the lesion.
- The Eastern Cooperative Oncology Group (ECOG) score for physical fitness is 0 or Expected survival period ≥ 3 months.
- During the screening period, the main organ functions were basically normal [no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the experimental drug]
- During the screening period, women of childbearing age with negative blood pregnancy test results and reproductive age subjects (including male subjects) who have no pregnancy plans during the trial period and within 6 months after the last dose and voluntarily take effective contraceptive measures.
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Patients with tumors as specified in the protocol
- Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.
- Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
- Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first administration.
- The screening period is accompanied by severe, progressive, or uncontrolled diseases, and it has been assessed by the researchers that participation in the study would increase the risk for the subjects.
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- History of interstitial lung disease/non infectious pneumonia in the past, currently suffering from interstitial lung disease/non infectious pneumonia, or suspected interstitial lung disease/non infectious pneumonia that cannot be excluded through imaging examination during screening.
- Subjects who have experienced severe infections within 4 weeks prior to their first medication. Active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first medication. Subjects receiving prophylactic antibiotic treatment can be enrolled.
- Participants who have participated in any clinical trial as subjects within the first 3 months of enrollment (excluding subjects who have only participated in clinical trial screening and have not used the investigational drug).
- According to the judgment of the investigator, there are concomitant diseases (such as severe diabetes, thyroid disease, etc.) that seriously endanger the safety of the subject or affect the completion of the study.
- 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 participants who are not suitable for enrollment.
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
Cancer Hospital of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Jing Huang, Doctor
About this study
Official title: An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of SIBP-A17 Formulation for Injection in Subjects With Advanced Solid Tumors.
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Read the detailed description
This study is an open, dose expanding, and indication expanding study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, QT/QTc interval effects and explore potential biomarkers of SIBP-A17 in patients with advanced solid tumors.
This study is divided into two 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, adopting an improved "3+3" dose escalation design, with a planned enrollment of 14-36 participants. The second stage is the dose expansion stage, where one or two doses are selected to enter the dose expansion phase (4 indication cohorts). 20-40 late-stage solid tumor participants are enrolled in each dose group for dose expansion, and 80-160 participants are planned to be enrolled in the dose expansion phase.
After obtaining certain safety and pharmacokinetic data during the dose escalation phase, the Safety Monitoring Committee (SMC) can discuss and decide whether to synchronize dose expansion.
- Conditions
- Advanced Solid Tumor
- Being tested
- SIBP-A17
- Keywords
- Advanced solid tumor, Her2-ADC, Safety, Efficacy, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A17Drug
Also called Her2-ADC
Strength: 1, 2, 4, 5, 6 or 8 mg. 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 subject. 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, and the dose exploration starting from 4mg/kg will adopt a "3+3" dose escalation design.
| Study group | Role | What they receive |
|---|---|---|
| SIBP-A17 | Experimental | SIBP-A17 is an Her2-ADC drug. Receives: Drug: SIBP-A17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
During the dose escalation phase, the first treatment cycle (21 days after the first dose) after the subject's administration was determined by the investigator to have occurred events related to the investigational drug as specified in the protocol.
Measured: Day 126
Maximum tolerated dose (MTD)
The maximum tolerated dose (MTD) refers to the highest dose at which DLT does not occur in <1/3 of subjects or ≤ 1/6 of subjects during the DLT observation period.
Measured: Day 260
Recommended Phase II Dose (RP2D)
Recommended Phase II Dose The optimal dose for phase II clinical trial research obtained based on clinical trial results of phase I and literature review.
Measured: Day 518
Adverse Events (AE)
That is adverse events, any adverse events that occurred to the participant during the study period.
Measured: 28 days
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: 15 days
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: 15 days
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: 5 months
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: 5 months
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: 5 months
OS (overall survival)
From randomization to time of death due to any cause.
Measured: 5 months
Δ QTcF
Changes in Δ QTcF (post administration QTcF baseline QTcF) at various time points after administration.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start23 Jul 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 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, dose expanding, and indication expanding study.
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, Doctor, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512116
- Sponsor's protocol ID
- SIBP-A17-I
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 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
- An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of SIBP-A17 Formulation for Injection in Subjects With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06512116
- Acronym / sponsor ID
- SIBP-A17-I
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced solid tumor, Her2-ADC, Safety, Efficacy, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jul 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-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Detailed description
This study is an open, dose expanding, and indication expanding study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, QT/QTc interval effects and explore potential biomarkers of SIBP-A17 in patients with advanced solid tumors.
This study is divided into two 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, adopting an improved "3+3" dose escalation design, with a planned enrollment of 14-36 participants. The second stage is the dose expansion stage, where one or two doses are selected to enter the dose expansion phase (4 indication cohorts). 20-40 late-stage solid tumor participants are enrolled in each dose group for dose expansion, and 80-160 participants are planned to be enrolled in the dose expansion phase.
After obtaining certain safety and pharmacokinetic data during the dose escalation phase, the Safety Monitoring Committee (SMC) can discuss and decide whether to synchronize dose expansion.
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, dose expanding, and indication expanding study.
| Arm | Type | Receives |
|---|---|---|
| SIBP-A17 | Experimental | Drug: SIBP-A17SIBP-A17 is an Her2-ADC drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age range of 18 to 75 years old (including boundary values), gender not limited.
- The clinical diagnosis of enrolled subjects should meet the following criteria:
- Advanced solid tumor subjects confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples (only applicable during dose expansion phase).
- There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 criteria, CT or MRI). Lesions that have received previous radiotherapy or other local treatments are not considered as target lesions unless there is clear progression of the lesion.
Key exclusion criteria (13 listed)
- Patients with tumors as specified in the protocol
- Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.
- Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
- Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serosal fluid 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-A17Also: Her2-ADCStrength: 1, 2, 4, 5, 6 or 8 mg. 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 subject. 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, and the dose exploration starting from 4mg/kg will adopt a "3+3" dose escalation design. | Drug | SIBP-A17 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Day 126
During the dose escalation phase, the first treatment cycle (21 days after the first dose) after the subject's administration was determined by the investigator to have occurred events related to the investigational drug as specified in the protocol.
Maximum tolerated dose (MTD)
Time frame: Day 260
The maximum tolerated dose (MTD) refers to the highest dose at which DLT does not occur in <1/3 of subjects or ≤ 1/6 of subjects during the DLT observation period.
Recommended Phase II Dose (RP2D)
Time frame: Day 518
Recommended Phase II Dose The optimal dose for phase II clinical trial research obtained based on clinical trial results of phase I and literature review.
Adverse Events (AE)
Time frame: 28 days
That is adverse events, any adverse events that occurred to the participant during the study period.
7 secondary outcomes
AUC (Area Under The Plasma Concentration Versus Time Curve)
Time frame: 15 days
Cmax (Peak Plasma Concentration)
Time frame: 15 days
ORR(Objective Response Rate)
Time frame: 5 months
DCR (Disease control rate)
Time frame: 5 months
PFS(Progression-free survival)
Time frame: 5 months
OS (overall survival)
Time frame: 5 months
Δ QTcF
Time frame: 15 days
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, Doctor principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical
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-A17 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 15 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 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?
Dose limiting toxicity (DLT) (time frame: Day 126). 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 7 Jan 2026.