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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase I/II Clinical Study of 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04818333
• Other study ID #: SHR-A1811-I-103
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 23, 2021
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 157
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• SHR-A1811
Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811	Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)	From Day 1 to90 days after last dose ,appropriately to 3 years
Primary	Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811	Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)	From Day 1 to90 days after last dose ,appropriately to 3 years
Primary	Phase1: Maximum tolerated dose (MTD)	Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment	12 months
Primary	Phase 1: Recommended Phase 2 dose (RP2D)	RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained	12 months
Primary	Phase2:ObjectiveResponse Rate (ORR)	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)	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
Secondary	Phase 1:PK parameter :Tmax of SHRA1811	Time to maximal concentration (Tmax) of SHR-A1811	appropriately to 3 years
Secondary	Phase1:PK parameter: Cmax of SHR-A1811	Maximal concentration (Cmax) of SHR-A1811	appropriately to 3 years
Secondary	Phase1:PK parameter: AUC0-t of SHR-A1811	AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811	appropriately to 3 years
Secondary	Phase1:Immunogenicity of SHR-A1811	Including anti-drug antibody and/or neutralizing antibody	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
Secondary	Phase2:Progression Free Survival (PFS)	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator	appropriately to 3 years
Secondary	Phase2:ObjectiveResponse Rate (ORR)	As assessed by RECIST v1.1 , as assessed by investigator	appropriately to 3 years
Secondary	Phase2:Duration of response (DOR)	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator	appropriately to 3 years
Secondary	Phase2:Disease control rate (DCR)	As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator	appropriately to 3 years
Secondary	Phase2:Overall survival (OS)		Approximately 5 years after last subject enrolled