The Phase I Study of SIG001 Antibody on Cancer Therapy. (NCT07486700) | Clinical Trial Compass
Not Yet RecruitingPhase 1
The Phase I Study of SIG001 Antibody on Cancer Therapy.
China66 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✕. 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:
✕. 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;