A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT05949606 | Recruiting Phase 1

• 1 other identifier: SI-B001-SI-B003-202
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Phase Ib/II: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B001+SI-B003.

  Up to approximately 24 months

• Phase Ib/II: 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

• Phase Ib: Dose Limited Toxicity (DLT)

  The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

  Up to approximately 24 months

• Phase Ib: Maximum Tolerated dose (MTD) or maximum administered dose (MAD)

  In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

  Up to approximately 24 months

Secondary Outcomes (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Phase Ib/II: Disease control rate (DCR)

  Up to approximately 24 months

• Phase Ib/II: Duration of response (DOR)

  Up to approximately 24 months

• Phase Ib/II: Progression-free survival (PFS)

  Up to approximately 24 months

• Phase Ib/II: Cmax

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

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.

Drug: SI-B001; Drug: SI-B003

Interventions

SI-B001 DRUG

Administration by intravenous infusion

Study treatment

SI-B003 DRUG

Administration by intravenous infusion

Study treatment

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 ≥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.

You may not qualify if:

• Prior to signing the informed consent form, relevant genetic alterations were indicated;
• For patients enrolled in Phase II, any of the following conditions apply: a) Patients suitable for and willing to undergo local therapy; b) Patients who have received systemic chemotherapy;
• Symptomatic brain parenchymal or leptomeningeal metastases, deemed ineligible by the investigator;
• Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);
• Use of chemotherapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose, or palliative radiotherapy, small-molecule targeted therapy, or other antitumor treatments within 2 weeks before the first dose;
• Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;
• Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;
• Pulmonary diseases graded as ≥3 according to NCI-CTCAE v5.0; history of interstitial lung disease (ILD), current ILD, or suspected ILD during screening;
• Concurrent pulmonary disease resulting in clinically significant respiratory impairment;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening (excluding catheter-related thrombosis);
• Active infection requiring intravenous anti-infective therapy;
• Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels, with a risk of bleeding post antitumor therapy;
• Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;
• Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;
• Use of immunomodulatory drugs within 14 days before the first dose of the study drug;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Caicun Zhou, PHD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CN (1)