RecruitingPhase 1Phase 2NCT05949606

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

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)


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

160 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two experimental antibody drugs (SI-B001 and SI-B003), with or without chemotherapy, in people with locally advanced or metastatic non-small cell lung cancer (NSCLC). These drugs target proteins on cancer cells to help the immune system fight the cancer. **You may be eligible if...** - You are 18 to 75 years old with confirmed advanced or metastatic NSCLC - You have at least one measurable tumor - Your overall health and organ function meet required levels - You are willing to provide a tumor tissue sample - You have not received prior anti-cancer treatment for this advanced disease (for Phase II patients) **You may NOT be eligible if...** - You have certain known genetic mutations in your tumor (tested before enrollment) - You have active or symptomatic brain metastases - You have a history of severe interstitial lung disease - You have active autoimmune disease or have been on immunosuppressants recently - You are HIV positive or have active hepatitis B or C - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGSI-B001

Administration by intravenous infusion

DRUGSI-B003

Administration by intravenous infusion


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT05949606


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