A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

NCT06990464 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-A19-I
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumor; ADC; Safety; Efficacy; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• AE (Adverse Events)

  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

• Phase II recommended dose (RP2D)

  RP2D refers to the recommended dose determined through initial dose escalation and toxicity assessment in clinical trials, used for further evaluation of drug efficacy and safety.

  Day 21 after the last dose in the dose expansion phase

• Dose-limiting toxicity (DLT)

  DLT is defined as any adverse event related to the drug defined in the protocol that occurs within 21 days of the first cycle after a single administration.

  Day 21 after each dose in the dose escalation stage

• Maximum tolerated dose (MTD)

  MTD is defined as the maximum dose at which the number of DLT cases occurring during the DLT observation period within 21 days after a single administration is ≤ 1/6 of the total number of cases.

  Day 21 after the last dose in the dose escalation stage

Secondary Outcomes (7)

• AUC (Area Under The Plasma Concentration Versus Time Curve)

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

• Cmax (Peak Plasma Concentration)

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

• Tmax (Peak Time)

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

• ORR (Objective Response Rate)

  6 weeks after the last evaluation

• DCR (Disease control rate)

  6 weeks after the last evaluation

Study Arms (1)

SIBP-A19

EXPERIMENTAL

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

Drug: SIBP-A19

Interventions

SIBP-A19 DRUG

SIBP-A19 formulation for injection. 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-A19

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.
• Voluntarily participate in this study and sign the informed consent form.
• Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance.
• Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements.
• There must be at least one measurable lesion as the target lesion.
• 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.

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)

The Union Hospital affiliated to Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Study Officials

• Ling ying Wu

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan dan Chen, Master

CONTACT

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

Wen qing Chai

CONTACT

86-021-62800991; chaiwenqing@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, multicenter, dose escalation, dose expansion, and indication expansion study.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)