Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

NCT06434103 | Withdrawn Phase 1

• 1 other identifier: SHR-A1921-205
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer

Conditions

Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• DLT

  21 days after the first dose

• ORR based on RECIST v1.1 assessment.

  All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

Secondary Outcomes (2)

• Adverse event

  All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years

• DCR based on RECIST v1.1 assessment

  All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

Study Arms (1)

SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin

EXPERIMENTAL

Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin

Interventions

SHR-A1921；Adebrelimab；SHR-8068；carboplatin DRUG

SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.

SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
• Aged 18-75 at the time of signing the informed consent;
• Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
• At least one measurable lesion consistent with RECIST v1.1;
• ECOG PS score: 0-1;
• The organ function level is good;

You may not qualify if:

• Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
• Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
• Previous or co-existing malignant neoplasms;
• The presence of any active or known autoimmune disease;
• Have clinical symptoms or diseases of the heart that are not well controlled;
• People with past or current interstitial pneumonia/interstitial lung disease;
• Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
• Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

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: May 23, 2024
• First Posted: May 30, 2024
• Study Start: October 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04