Clinical trial NCT04818333: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of SHR-A1811
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
timeFrame: From Day 1 to90 days after last dose ，appropriately to 3 years
measure: Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
timeFrame: From Day 1 to90 days after last dose ，appropriately to 3 years
measure: Phase1: Maximum tolerated dose (MTD)
timeFrame: 12 months
measure: Phase 1: Recommended Phase 2 dose (RP2D)
timeFrame: 12 months
measure: Phase2:ObjectiveResponse Rate (ORR)
timeFrame: 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 outcomes:
measure: Phase 1：PK parameter ：Tmax of SHRA1811
timeFrame: appropriately to 3 years
measure: Phase1:PK parameter: Cmax of SHR-A1811
timeFrame: appropriately to 3 years
measure: Phase1:PK parameter: AUC0-t of SHR-A1811
timeFrame: appropriately to 3 years
measure: Phase1:Immunogenicity of SHR-A1811
timeFrame: 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
measure: Phase2:Progression Free Survival (PFS)
timeFrame: appropriately to 3 years
measure: Phase2:ObjectiveResponse Rate (ORR)
timeFrame: appropriately to 3 years
measure: Phase2:Duration of response (DOR)
timeFrame: appropriately to 3 years
measure: Phase2:Disease control rate (DCR)
timeFrame: appropriately to 3 years
measure: Phase2:Overall survival (OS)
timeFrame: Approximately 5 years after last subject enrolled
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: