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RecruitingPhase 1Phase 2NCT06589778

A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

124 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Summary

This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  • Age 18~70 years old.
  • Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • ECOG PS score: 0-1.

Exclusion Criteria6

  • Active or symptomatic brain metastases.
  • Previous diagnosis of any other malignancy.
  • Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
  • Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
  • Uncontrolled tumor-related pain.
  • Subjects with severe cardiovascular and cerebrovascular diseases.

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Interventions

DRUGSHR-A2102

SHR-A2102: injection, 80mg/ bottle, intravenous drip

DRUGAdebelimab (SHR-1316)

Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip

DRUGSHR-8068

SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip

Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06589778