A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC

NCT07264816 | Recruiting Phase 2

• 1 other identifier: BL-M07D1-207
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 24 months

• Combined optimal dosage

  The combined optimal dosage will be investigated.

  Up to approximately 24 months

• Combination method

  The combination method will be investigated.

  Up to approximately 24 months

Secondary Outcomes (10)

• Progression-free Survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-M07D1+pembrolizumab

EXPERIMENTAL

Participants received BL-M07D1+pembrolizumab 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.

Drug: BL-M07D1; Drug: Pembrolizumab

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1+pembrolizumab

Pembrolizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1+pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 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 restrictions;
• Age at the time of signing the informed consent form ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
• Confirmed known HER2 overexpression;
• Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;
• Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
• ECOG performance status score of 0 or 1;
• Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should take adequate and highly effective contraception throughout the treatment cycle and for 7 months after the end of treatment.

You may not qualify if:

• Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
• Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
• Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
• History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
• Concurrent pulmonary disease leading to severe impairment of lung function;
• QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
• Diagnosed with other primary malignancies within 5 years before the first dose;
• Poorly controlled hypertension;
• History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD/interstitial pneumonia, etc.;
• Patients with central nervous system metastases, carcinomatous meningitis, and/or spinal cord compression;
• Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-M07D1, pembrolizumab, or any excipient components;
• Required systemic corticosteroid or immunosuppressive therapy within 2 weeks before the study administration;
• Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
• New deep vein thrombosis within 14 days, excluding patients with venous filters implanted;
• Systemic severe infection within 4 weeks before screening;

Sponsors & Collaborators

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

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab

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: November 24, 2025
• First Posted: December 4, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)