A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.

NCT ID: NCT06298058

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2026-06-30

Brief 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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIBP-A13

SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion).

Group Type: EXPERIMENTAL

SIBP-A13 formulation for injection

Intervention Type: DRUG

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.

Interventions

SIBP-A13 formulation for injection

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.

Intervention Type: DRUG

Other Intervention Names

Her3-ADC

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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.

2. 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.
• 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.

Exclusion Criteria

• 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:

• 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.

1. Hypertension that cannot be controlled clinically.

2. Diabetes with poor drug control.

3. Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caicun Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dandan Chen, Master

Role: CONTACT

ddchen.sh@sinopharm.com

86-021-62800991

Yanni Zhou, Master

Role: CONTACT

zhouyanni3@sinopharm.com

86-021-62800991

Facility Contacts

Caicun Zhou, Doctor

Role: primary

Other Identifiers

SIBP-A13-I

Identifier Type: -

Identifier Source: org_study_id