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A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntarily sign the informed consent form and comply with the protocol requirements;

• No gender restriction;

• Age: ≥18 years;

• Expected survival time ≥3 months;

• Histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;

• Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;

• Must have at least one measurable lesion as defined by RECIST v1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;

⁃ No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;

⁃ Organ function levels must meet the required criteria;

⁃ Urine protein ≤1+ or ≤1000 mg/24h;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment. Serum pregnancy testing must rule out pregnancy, and the patient must not be breastfeeding. All enrolled trial participants (regardless of gender) should take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2026-07-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 36
Treatments
Experimental: BL-M14D1+ Atezolizumab
Participants receive BL-M14D1+ Atezolizumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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