The Phase I Study of SIG001 Antibody on Cancer Therapy.
ConditionNeoplams
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- SIG001
- SIG001
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University
Lead sponsor
Peking University Cancer Hospital & Institute
Sponsor institution
Peking Union Medical College Hospital
Collaborator
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
Source ClinicalTrials.gov