The Phase I Study of SIG001 Antibody on Cancer Therapy.

NCT07486700 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025YW315
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn the safty characteristics of SIG001 Mab in cancer patients; It will also determine the Recommended Phase II dose of SIG001 Mab on cancer treatment, and pharmacological characteristics of SIG001. The main questions it aims to answer are: What is the safety and tolerability of SIG001 in patients with advanced solid tumors ? What is the Recommended Phase II dose of SIG001? What is the PK/PD characteristics of SIG001 in cancer patients? What is the antitumor activity of SIG001 in cancer patients? What is the immunogenicity of SIG001 in cancer patients? What is the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy? What is the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety? What is event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001? This will be a single-armed study. Participants will: Intravenously Inject SIG001 every two weeks, for 4 weeks Visit the clinic on the 14th day, 30th day, and 90th day afer the last injection. Then visit the clinic for every 12 weeks.

Conditions

Neoplams

Keywords

neoplams; tumor IgG; sialylated IgG

Outcome Measures

Primary Outcomes (3)

• DLT

  Dose limited toxicity evaluated in the first cycle of treatment

  up to 28 days

• Maximum Plasma Concentration [Cmax]

  Maximum Plasma Concentration \[Cmax\]

  up to 28 days

• incidence rate of Adverse events

  incidence rate of Adverse events occured during treatment

  up to 28 days

Secondary Outcomes (1)

• Tumor assessment

  up to 56 days

Study Arms (2)

Dose-escalation study group

EXPERIMENTAL

In is group of study, the safty characteristics of SIG001 will be determined by escalating dosage of SIG001. 36 patients will participate in this group.

Biological: SIG001

Dose Expansion Study Group

EXPERIMENTAL

In this group of study, the Recommended Phase II dose of SIG001 will be determined. 30 patients will join this group.

Biological: SIG001

Interventions

SIG001 BIOLOGICAL

Intravenous administration. The dose-escalation study was conducted using a BOIN design. The starting dose in the escalation regimen was 0.15 mg/kg Q2W. The dose increases were at rates of 167%, 150%, 80%, 94.4%, and 71.4%, respectively, until a dose of 6 mg/kg was reached.

Dose-escalation study group

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for this clinical study:
• The subject must fully understand the requirements of this study and voluntarily sign a written informed consent form. They must also be able to comply with the study's medication regimen as well as all related procedures and assessments;
• Age must be \>=18 and \<=75 years old, with no gender restriction;
• Subjects must have locally advanced, recurrent, or metastatic malignant tumors that have failed standard treatment or are not tolerant to it, and for which there is no effective standard treatment option. Histological or cytological confirmation is required;
• According to RECIST v1.1, the subject must have at least 1 measurable target lesion. At baseline, the lesion must be accurately measurable by computed tomography (CT) or magnetic resonance imaging (MRI) - preferably with intravenous contrast agent. The long diameter of non-lymph node lesions must be ≥10 mm, and the short axis of lymph node lesions must be \>=15 mm. The lesion must be suitable for repeated and accurate measurements. If a lesion in a previously irradiated area shows clear progression, it can also be considered a measurable target lesion;
• The expected survival time must be \>=12 weeks;
• The Eastern Cooperative Oncology Group performance status score must be 0 or 1;
• Subjects must have adequate function of vital organs at the time of screening. This requires that no blood transfusions, hematopoietic stimulants, or human albumin preparations have been used within 14 days prior to screening. The specific criteria are as follows:
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• Blood tests: Absolute neutrophil count \>=1.5 × 10\^9/L; Platelet count \>=75 × 10\^9/L; Hemoglobin \>=90 g/L;
• Liver function: Serum TBIL \<=1.5 × ULN. For patients with liver metastases or Gilbert's syndrome, TBIL \<=3 × ULN. For subjects without liver metastases, ALT and AST \<=2.5 × ULN; for those with liver metastases, ALT and AST \<=5 × ULN;
• Coagulation function: Activated partial thromboplastin time and International normalized ratio \<=1.5 × ULN (for subjects on anticoagulant therapy, these values must be within the therapeutic range).
• Renal function: Creatinine clearance rate \>=60 mL/min, calculated using the Cockcroft-Gault formula;
• Cardiac function: Echocardiography shows left ventricular ejection fraction greater than 50%; 8. Female subjects of childbearing age must have a negative pregnancy test within 7 days before receiving the study drug for the first time. Eligible male and female subjects must agree to use reliable contraceptive methods (hormonal, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of the drug. Eligible subjects are defined as being sexually mature and biologically capable of reproducing.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria:
• SIG001 is administered during the washout period following previous antineoplastic therapy (4 weeks or 5 half-lives after the last dose, whichever is shorter);
• Received radiotherapy within 28 days prior to the first dose of SIG001;
• Had a history of other malignant tumors within 5 years prior to the first dose (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma that has been cured with no evidence of recurrence, breast/cervical carcinoma in situ, superficial bladder carcinoma, and other in situ cancers);
• Subjects with any of the following cardiovascular diseases:
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• Symptomatic heart failure (New York Heart Association functional class \>=2, see Appendix 4);
• Uncontrolled hypertension despite standard treatment (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=100 mmHg);
• Resting mean corrected QT interval \> 470 ms on a 12-lead electrocardiogram (QTc, using Fridericia's correction formula) on three repeated measurements. Various clinically significant arrhythmias, conduction abnormalities, and resting ECG abnormalities, such as complete left bundle branch block, third-degree block, second-degree block, and PR interval \> 250 ms. Factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or sudden death before age 40, and use of medications known to prolong QTc;
• Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, percutaneous coronary intervention or coronary artery bypass grafting within 6 months prior to screening;
• Any cause of cardiomyopathy;
• Clinically significant valvular heart disease;
• History of atrial or ventricular arrhythmias that require treatment; subjects with atrial fibrillation and well-controlled ventricular rate may be enrolled;
• Transient ischemic attack or stroke within 6 months prior to screening; 6. Subjects with infectious diseases, including;
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Sponsors & Collaborators

• Peking University: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Guangzhou SIG Biomedical Technology Co., Ltd.: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

• Lin Shen, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jifang Gong

CONTACT

86 13683208528; goodjf@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor, Doctoral Supervisor; Director of the Department of Gastrointestinal Oncology and Director of the Phase I Clinical Trial Ward

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)