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

NCT06589778 | Recruiting Phase 1

• 1 other identifier: SHR-A2102-206
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Determination of Recommended Phase II dose (RP2D)

  From first dose of study treatment until the end of Cycle 1（up to 21 days）

• Objective Response Rate (ORR)

  The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

  From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

• Incidence and severity of AEs

  The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

• Duration of Response (DoR)

  From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]

• Progression free Survival (PFS)

  From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)

• Overall Survival (OS)

  From time of first dose of objective disease progression until the date of death (up to 24 months)

Study Arms (1)

SHR-A2102 in Combination with Adebrelimab and SHR-8068

EXPERIMENTAL

Drug: SHR-A2102; Drug: Adebelimab (SHR-1316); Drug: SHR-8068

Interventions

SHR-A2102 DRUG

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

SHR-A2102 in Combination with Adebrelimab and SHR-8068

Adebelimab (SHR-1316) DRUG

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

SHR-A2102 in Combination with Adebrelimab and SHR-8068

SHR-8068 DRUG

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

SHR-A2102 in Combination with Adebrelimab and SHR-8068

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, 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

Central Study Contacts

Xin Xu

CONTACT

0518-82342973; xin.xu@hengrui.com

Yunfei Zhang

CONTACT

0518-82342973; yunfei.zhang.yz277@hengrui.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: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-09

Locations

CN (1)