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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Sign the informed consent form voluntarily and follow the protocol requirements;

• Gender is not limited;

• Age: ≥18 years old and ≤75 years old;

• Expected survival time ≥3 months;

• Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;

• Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;

• At least one measurable lesion meeting the RECIST v1.1 definition was required;

• ECOG 0 or 1;

• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

⁃ No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements;

⁃ Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;

⁃ Urinary protein ≤2+ or ≤1000mg/24h;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Hunan Cancer Hospita
NOT_YET_RECRUITING
Changsha
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Linyi Cancer Hospital
RECRUITING
Linyi
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuzhou
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
The Second Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi’an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
+8615013238943
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2027-12
Participants
Target number of participants: 121
Treatments
Experimental: Study treatment
Participants received SI-B003 and BL-B01D1+SI-B003 in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov