A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Phase Ib: To observe the safety and tolerability of the combination of SI-B001 and SI-B003, and to determine the recommended dose of phase II clinical study (RP2D) in the indication of locally advanced or metastatic non-small cell lung cancer. Phase II: To evaluate the efficacy of SI-B001+SI-B003 combination with or without chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
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;

• Expected survival time ≥3 months;

• Subjects must agree to complete ctDNA testing during the screening period;

• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) patients;

• Agree to provide archived or fresh tumor tissue samples from primary or metastatic lesions;

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

• Performance status score: ECOG ≤1;

⁃ Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

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

⁃ Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;

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

⁃ Urine protein ≤1+ or ≤1000 mg/24h;

⁃ Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.

Locations
Other Locations
China
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
+8615013238943
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 160
Treatments
Experimental: Study treatment
Participants will receive treatment during the first cycle. Participants with clinical benefits received more cycles of additional therapy. Administration will be discontinued due to disease progression or occurrence of intolerable toxicity or other reasons.
Sponsors
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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