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

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1811
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-A1811

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)
Phase1: Maximum tolerated dose (MTD)
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment
Phase 1: Recommended Phase 2 dose (RP2D)
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Phase2:ObjectiveResponse Rate (ORR)
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)

Secondary Outcome Measures

Phase 1：PK parameter ：Tmax of SHRA1811
Time to maximal concentration (Tmax) of SHR-A1811
Phase1:PK parameter: Cmax of SHR-A1811
Maximal concentration (Cmax) of SHR-A1811
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
Phase1:Immunogenicity of SHR-A1811
Including anti-drug antibody and/or neutralizing antibody
Phase2:Progression Free Survival (PFS)
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Phase2:ObjectiveResponse Rate (ORR)
As assessed by RECIST v1.1 , as assessed by investigator
Phase2:Duration of response (DOR)
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Phase2:Disease control rate (DCR)
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Phase2:Overall survival (OS)

Full Information

First Posted
March 25, 2021
Last Updated
May 9, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04818333
Brief Title
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm study of SHR-A1811
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-A1811
Arm Type
Experimental
Arm Description
SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
Intervention Type
Drug
Intervention Name(s)
SHR-A1811
Intervention Description
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
Primary Outcome Measure Information:
Title
Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
Description
Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Time Frame
From Day 1 to90 days after last dose ，appropriately to 3 years
Title
Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
Description
Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Time Frame
From Day 1 to90 days after last dose ，appropriately to 3 years
Title
Phase1: Maximum tolerated dose (MTD)
Description
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment
Time Frame
12 months
Title
Phase 1: Recommended Phase 2 dose (RP2D)
Description
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Time Frame
12 months
Title
Phase2:ObjectiveResponse Rate (ORR)
Description
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)
Time Frame
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 Outcome Measure Information:
Title
Phase 1：PK parameter ：Tmax of SHRA1811
Description
Time to maximal concentration (Tmax) of SHR-A1811
Time Frame
appropriately to 3 years
Title
Phase1:PK parameter: Cmax of SHR-A1811
Description
Maximal concentration (Cmax) of SHR-A1811
Time Frame
appropriately to 3 years
Title
Phase1:PK parameter: AUC0-t of SHR-A1811
Description
AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
Time Frame
appropriately to 3 years
Title
Phase1:Immunogenicity of SHR-A1811
Description
Including anti-drug antibody and/or neutralizing antibody
Time Frame
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
Title
Phase2:Progression Free Survival (PFS)
Description
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Time Frame
appropriately to 3 years
Title
Phase2:ObjectiveResponse Rate (ORR)
Description
As assessed by RECIST v1.1 , as assessed by investigator
Time Frame
appropriately to 3 years
Title
Phase2:Duration of response (DOR)
Description
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Time Frame
appropriately to 3 years
Title
Phase2:Disease control rate (DCR)
Description
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator
Time Frame
appropriately to 3 years
Title
Phase2:Overall survival (OS)
Time Frame
Approximately 5 years after last subject enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 advanced non-small cell lung cancer with HER2 expression , amplification, or mutation 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. There is at least one measurable lesion according to RECIST V1.1 criteria Exclusion Criteria: Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. Has received HER2 antibody drug conjugates, Central nervous system metastasis or meningeal metastasis with clinical symptoms Has active infection requiring systemic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Shi, MD,PhD
Phone
+86 021-61053363
Email
Shiwei@hrglobe.cn
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Lu, Doctor

12. IPD Sharing Statement

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

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