A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

NCT06985368 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-A18-I
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors

Conditions

Solid Tumor Malignancy

Keywords

Solid Tumor Malignancy; ADC; Safety; Efficacy; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Adverse Events (AE)

  That is adverse events, any adverse events that occurred to the participant during the study period.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 1, Day 22 and Day 63 after the first dose

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  6 weeks after the last evaluation

• Disease control rate (DCR)

  6 weeks after the last evaluation

• Progression-free survival (PFS)

  6 weeks after the last evaluation

• overall survival (OS)

  6 weeks after the last evaluation

Study Arms (1)

SIBP-A18

EXPERIMENTAL

The participants enrolled will be sequentially assigned to the corresponding dose level.

Drug: SIBP-A18

Interventions

SIBP-A18 DRUG

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.

SIBP-A18

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Jing Huang, Docter

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen, Master

CONTACT

86-021-62800991; ddchen.sh@sinopharm.com

Bin Wu, Bachelor

CONTACT

86-021-62800991; wubin50@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is an open, multi dose increasing single and multiple dose study.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)