RecruitingPhase 2NCT05956587

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

121 participants

Start Date

Jan 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two experimental drugs — SI-B003 alone and SI-B003 combined with BL-B01D1 — in patients with advanced solid tumors including non-small cell lung cancer and nasopharyngeal carcinoma (a type of head and neck cancer). The goal is to assess how safe these treatments are and how well they work. **You may be eligible if...** - You are 18 to 75 years old with a confirmed advanced or metastatic solid tumor - Your cancer has measurable disease and your general health is good (ECOG 0 or 1) - Your major organs (heart, liver, kidneys) are functioning adequately - You have recovered from side effects of prior treatments **You may NOT be eligible if...** - You received chemotherapy or immunotherapy within 4 weeks of starting - You previously had severe immune-related side effects (grade 3 or higher) from immunotherapy - You have an active autoimmune disease, HIV, active hepatitis B or C - You have active brain metastases, a history of organ transplant, or severe heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion

DRUGSI-B003

Administration by intravenous infusion


Locations(16)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospita

Changsha, Hunan, China

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Linyi Cancer Hospital

Linyi, Shangdong, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05956587


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