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

RECRUITINGPhase 1/2Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.
Actively Recruiting
PhasePhase 1/2
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
Started2024-09-27
Est. completion2026-04-30
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

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

Conditions3

CancerLung CancerNon Small Cell Lung Cancer

Interventions3

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