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

NCT07654400 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-M14D1-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Progression-free survival (PFS)

  Up to approximately 12 months

• Disease Control Rate (DCR)

  Up to approximately 12 months

• Duration of Response (DOR)

  Up to approximately 12 months

• Overall Survival (OS)

  Up to approximately 12 months

• Cmax

  Up to approximately 12 months

Study Arms (1)

BL-M14D1+ Atezolizumab

EXPERIMENTAL

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; Drug: Atezolizumab

Interventions

BL-M14D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M14D1+ Atezolizumab

Atezolizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M14D1+ Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
• Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;
• Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;
• Use of immunomodulatory drugs within 2 weeks before the first dose of the study;
• Receiving long-term systemic corticosteroid therapy at a dose \>10 mg/day of prednisone or equivalent before the first dose;
• History of severe cardiovascular or cerebrovascular diseases;
• Prolonged QTc interval, complete left bundle branch block, etc.;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another malignancy within 5 years before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs;
• Patients with poorly controlled blood glucose;
• History of ILD/interstitial pneumonia treated with corticosteroids, etc.;
• Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;
• Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;
• Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CN (1)