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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is an open-label, multicenter, dose-escalation and cohort-expansion, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.

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 restrictions;

• Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);

• Expected survival time ≥3 months;

• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer or other solid tumors that have failed standard treatment;

• Willing to provide archived or fresh tumor tissue samples from primary or metastatic lesions within the past 2 years;

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

• ECOG performance status score of 0 or 1;

• Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

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

⁃ Organ function levels must meet the requirements;

⁃ Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);

⁃ Urine protein ≤2+ or ≤1000mg/24h;

⁃ For premenopausal women with childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment completion;

⁃ The subject has the ability and willingness to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the protocol.

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 31
Treatments
Experimental: BL-M09D1
Participants receive BL-M09D1 as intravenous infusion 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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