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

Phase 2Active Not RecruitingNCT04818333

Jiangsu HengRui Medicine Co., Ltd.157 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

SHR-A1811DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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)

Time frame: From Day 1 to90 days after last dose ，appropriately to 3 years

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)

Time frame: From Day 1 to90 days after last dose ，appropriately to 3 years

Phase1: Maximum tolerated dose (MTD)

Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment

Time frame: 12 months

Phase 1: Recommended Phase 2 dose (RP2D)

RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained

Time frame: 12 months

Phase2:ObjectiveResponse Rate (ORR)

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 Outcomes

Phase 1：PK parameter ：Tmax of SHRA1811

Time to maximal concentration (Tmax) of SHR-A1811

Time frame: appropriately to 3 years

Phase1:PK parameter: Cmax of SHR-A1811

Maximal concentration (Cmax) of SHR-A1811

Data from ClinicalTrials.gov

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