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NeoplamsPhase 1NCT07486700

The Phase I Study of SIG001 Antibody on Cancer Therapy.

A Phase 1 study testing SIG001 in people with Neoplams, run by Peking University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplams
What is being tested?
SIG001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
Mar 2026to Jul 2028
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

  • 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;
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  • 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.

Who cannot join

  • 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;
  • Acute toxicity resulting from previous antineoplastic therapy had not resolved to NCICTCAE 5.0 version grade ≤1 or to the baseline level specified in the inclusion criteria 4 weeks before the first dose of SIG001 (excluding hair loss or fatigue);
  • 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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  • Acute or chronic active hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (HbcAb) with HBV DNA >=100 IU/mL;
  • Acute or chronic active hepatitis C, i.e., positive for HCV antibodies with HCV-RNA levels above the upper limit of the central reference range;
  • HIV-infected individuals (positive for HIV 1/2 antibodies);
  • Active syphilis or active pulmonary tuberculosis; 7. Subjects with primary central nervous system tumors, meningeal metastases, spinal cord compression, or brainstem metastases; those with untreated brain metastases or symptomatic/stable conditions can be enrolled after at least 4 weeks of stable treatment; 8. Uncontrolled comorbidities, such as:
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  • Severe infections within 4 weeks prior to study initiation, including hospitalization due to infection, bacteremia, or severe pneumonia; subjects with uncontrolled active infections during screening can be enrolled if they receive prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease);
  • History of interstitial lung disease, unresolved radiation pneumonitis, acute episodes or progressive worsening of pulmonary symptoms at baseline, or factors that increase the risk of interstitial lung disease and pose a safety risk to the subject as assessed by the investigator;
  • Severe malnutrition requiring intravenous nutrition; subjects whose malnutrition has been corrected and stabilized for more than 4 weeks prior to the first dose can be enrolled;
  • Tumors invading vital organs or blood vessels, which may significantly increase treatment risk or affect efficacy assessment; subjects with a risk of esophagotracheal fistula or esophagothoracic fistula, or those within 4 weeks of esophageal or tracheal stent placement (subjects with stable conditions for more than 4 weeks can be enrolled);
  • History of gastrointestinal perforation and/or fistula within 6 months prior to screening;
  • Presence of uncontrolled effusions requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Subjects without the need for drainage or with no significant increase in effusion volume after 3 days of drainage cessation can be enrolled).
  • 9. Subjects who are expected to receive other antineoplastic treatments during the study period (palliative radiotherapy is allowed); 10. Subjects who have participated in clinical studies within 4 weeks prior to the first dose or plan to participate in other clinical studies during the study period; 11. Subjects who have received live vaccines within 4 weeks prior to the first dose; 12. Allergy to SIG001 or its components; 13. Pregnant women, lactating women, or women who plan to become pregnant during the study period; 14. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Subjects who have received systemic immunosuppressive therapy for autoimmune diseases within 2 years prior to dosing are excluded, except in the following cases:
  • Inhaled, topical, or intramuscular steroid use;
  • Systemic corticosteroids (dose not exceeding 10 mg/day of prednisone or equivalent);
  • Steroids used as premedication for hypersensitivity reactions (e.g., premedication for CT scans).
  • 16. Subjects with a history of mental disorders and those taking medication for treatment; 17. Subjects with a history of drug abuse or substance use; 18. Subjects who, in the judgment of the investigator, have other factors that may affect the study results or interfere with their participation in the entire study, including past or current health conditions, treatment or laboratory test abnormalities, and those who are unwilling to comply with the study procedures and requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jifang Gong contact

86 13683208528

goodjf@163.com

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: An Open-label, Phase I, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SIG001 in Subjects With Advanced Solid Tumors.

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?

Read more

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.

Read the detailed description

SIG001 is a innovative drug aimed on a novel cancer target. SIG001can band the sialylated IgGm(eg, SIG) expressed by the cancer cells. Based on the preclinical studies, SIG001 showed significant potential to inhibit all epithelial tumors, and especially to inhibit the metastasis/drug resistance/relapse of tumors. Therefore, SIG001 might be a promising broad-spectrum anti-tumor drag.

In this phase I clinical study, 66 patients will participate the trial. The major purpose of this trial is to study the safty characteristics and Recommended Phase II dose of SIG001, therefore the study is divided into to stages. In stage Ia, 36 patients will be in the study, they will be assigned into 6 dosage groups, the dosage of each group is based on BOIN design, from 0.15mg/kg, to 6mg/kg. The safty characteristics of SIG001will be summerized based on this stage. Then, the study will move forwad to stage Ib, In this stage, 30 patients will partticipate the study, to determine theRecommended Phase II dose of SIG001, to collect data for the phase II studies.

SInce SIG001 showed treatment potential for all the epithelial tumors, so that all epithelial tumor patients, who can meet the requirement of eligibility, can join this study.

Conditions
Neoplams
Being tested
SIG001
Keywords
neoplams, tumor IgG, sialylated IgG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIG001Biological

    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.

  • SIG001Biological

    At least 2 dosage levels will be selected for intravenous administration based on the safety and efficacy data from the dose-escalation studies.

Study groups in NCT07486700
Study groupRoleWhat they receive
Dose-escalation study groupExperimentalIn is group of study, the safty characteristics of SIG001 will be determined by escalating dosage of SIG001. 36 patients will participate in this group.
Receives: Biological: SIG001
Dose Expansion Study GroupExperimentalIn this group of study, the Recommended Phase II dose of SIG001 will be determined. 30 patients will join this group.
Receives: Biological: SIG001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Dose limited toxicity evaluated in the first cycle of treatment

    Measured: up to 28 days

  2. Maximum Plasma Concentration [Cmax]

    Maximum Plasma Concentration [Cmax]

    Measured: up to 28 days

  3. incidence rate of Adverse events

    incidence rate of Adverse events occured during treatment

    Measured: up to 28 days

Secondary outcomes (1)

  1. Tumor assessment

    Tumor effect assessment according to CT/MRI

    Measured: up to 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486700
Sponsor's protocol ID
2025YW315
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the tenical reason, the sharing of IPD cannot been guaranteed. Therefore for this study, the sponsor chose to not share IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIG001 in people with Neoplams, run by Peking University 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 14 inclusion and 32 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: opening soon, as of the sponsor's last update on 20 Mar 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 Jifang Gong (86 13683208528, goodjf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07486700.

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 20 Mar 2026.

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