A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

• Conditions: Advanced Non-small Cell Lung Cancer
• Interventions: Drug: SHR-A1811

• Registration Number: NCT04818333
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-04-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

1. Able and willing to provide a written informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
5. There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion Criteria

1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
2. Has received HER2 antibody drug conjugates,
3. Central nervous system metastasis or meningeal metastasis with clinical symptoms
4. Has active infection requiring systemic treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-A1811	SHR-A1811	SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment

Primary Outcome Measures

Name	Time	Method
Phase2:ObjectiveResponse Rate (ORR)	Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)
Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811	From Day 1 to90 days after last dose ，appropriately to 3 years	Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Phase 1: Recommended Phase 2 dose (RP2D)	12 months	RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811	From Day 1 to90 days after last dose ，appropriately to 3 years	Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Phase1: Maximum tolerated dose (MTD)	12 months	Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment

Secondary Outcome Measures

Name	Time	Method
Phase 1：PK parameter ：Tmax of SHRA1811	appropriately to 3 years	Time to maximal concentration (Tmax) of SHR-A1811
Phase2:Overall survival (OS)	Approximately 5 years after last subject enrolled
Phase1:Immunogenicity of SHR-A1811	Immunogenicity sample collection time points include: within 30 min before administration of C1D1, C2D1, C3D1, C4D1, C6D1 and C8D1 starting from cycle 11 only in every 3 cycles ,appropriately to 3 years	Including anti-drug antibody and/or neutralizing antibody
Phase1:PK parameter: Cmax of SHR-A1811	appropriately to 3 years	Maximal concentration (Cmax) of SHR-A1811
Phase2:ObjectiveResponse Rate (ORR)	appropriately to 3 years	As assessed by RECIST v1.1 , as assessed by investigator
Phase2:Duration of response (DOR)	appropriately to 3 years	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Phase2:Progression Free Survival (PFS)	appropriately to 3 years	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Phase1:PK parameter: AUC0-t of SHR-A1811	appropriately to 3 years	AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
Phase2:Disease control rate (DCR)	appropriately to 3 years	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China