A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: BL-M14D1; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai East Hospital
      • Contact: Caicun Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. No gender restriction;
3. Age: ≥18 years;
4. Expected survival time ≥3 months;
5. Histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;
6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
11. Organ function levels must meet the required criteria;
12. Urine protein ≤1+ or ≤1000 mg/24h;
13. 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.

Exclusion Criteria:

1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
2. Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;
3. Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;
4. Use of immunomodulatory drugs within 2 weeks before the first dose of the study;
5. Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent before the first dose;
6. History of severe cardiovascular or cerebrovascular diseases;
7. Prolonged QTc interval, complete left bundle branch block, etc.;
8. Active autoimmune diseases and inflammatory diseases;
9. Diagnosis of another malignancy within 5 years before the first dose;
10. Hypertension poorly controlled by two antihypertensive drugs;
11. Patients with poorly controlled blood glucose;
12. History of ILD/interstitial pneumonia treated with corticosteroids, etc.;
13. Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;
14. Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;
15. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;
16. Any thrombotic event within 6 months before randomization;
17. Patients with active central nervous system metastases;
18. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug, etc.;
19. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
20. Cumulative anthracycline dose >360 mg/m² during prior (neo)adjuvant anthracycline therapy;
21. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
22. Active infections requiring systemic treatment, or occurrence of severe infection within 4 weeks before informed consent;
23. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;
24. Pregnant or breastfeeding women;
25. History of severe neurological or psychiatric disorders;
26. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
27. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
28. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea;
29. Trial participants who plan to receive or have received live vaccines within 28 days before the first dose;
30. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: BL-M14D1; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Atezolizumab; Administration by intravenous infusion for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.	Up to approximately 12 months
Treatment-Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M14D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M14D1.	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.	Up to approximately 12 months
Disease Control Rate (DCR)	The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).	Up to approximately 12 months
Duration of Response (DOR)	The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.	Up to approximately 12 months
Overall Survival (OS)	Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.	Up to approximately 12 months
Cmax	Maximum serum concentration (Cmax) of BL-M14D1 will be investigated.	Up to approximately 12 months
Tmax	Time to maximum serum concentration (Tmax) of BL-M14D1 will be investigated.	Up to approximately 12 months
Ctrough	Ctrough is defined as the lowest serum concentration of BL-M14D1 prior to the next dose will be administered.	Up to approximately 12 months
ADA (anti-drug antibody)	Frequency of anti-BL-M14D1 antibody (ADA) will be investigated.	Up to approximately 12 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; atezolizumab
• Other Study ID Numbers: BL-M14D1-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No