A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT05880706
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion
  • Osimertinib Mesylate Tablets — DRUG
    Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.

Study Details

A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer.

Key Dates

Start date
Jul 19, 2023
Status verified
Sep 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
198 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study treatment
    Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets in 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.

Primary Outcome Measure

Recommended Phase II Dose (RP2D) [ Time Frame: Up to approximately 24 months ]

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