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

NCT ID: NCT06589778

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-A2102 in Combination with Adebrelimab and SHR-8068

Group Type EXPERIMENTAL

SHR-A2102

Intervention Type DRUG

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

Adebelimab (SHR-1316)

Intervention Type DRUG

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

SHR-8068

Intervention Type DRUG

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

Interventions

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SHR-A2102

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

Intervention Type DRUG

Adebelimab (SHR-1316)

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

Intervention Type DRUG

SHR-8068

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Xu

Role: CONTACT

0518-82342973

Yunfei Zhang

Role: CONTACT

0518-82342973

Facility Contacts

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Hua Zhong

Role: primary

Other Identifiers

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SHR-A2102-206

Identifier Type: -

Identifier Source: org_study_id

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