NCT07486700

The Phase I Study of SIG001 Antibody on Cancer Therapy.

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.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	SIG001	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.
BIOLOGICAL	SIG001	At least 2 dosage levels will be selected for intravenous administration based on the safety and efficacy data from the dose-escalation studies.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-04-01
• Completion: 2028-07-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: China