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

NCT04818333 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-A1811-I-103
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Phase 1: Recommended Phase 2 dose (RP2D)

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

  12 months

• 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 Outcomes (9)

• Phase 1：PK parameter ：Tmax of SHRA1811

  appropriately to 3 years

• Phase1:PK parameter: Cmax of SHR-A1811

  appropriately to 3 years

• Phase1:PK parameter: AUC0-t of SHR-A1811

  appropriately to 3 years

• 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

• Phase2:Progression Free Survival (PFS)

  appropriately to 3 years

Study Arms (1)

SHR-A1811

EXPERIMENTAL

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

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

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

SHR-A1811

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (2)

• Li Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25.

  PMID: 40020696 DERIVED

• Li Z, Song Z, Hong W, Yang N, Wang Y, Jian H, Liang Z, Hu S, Peng M, Yu Y, Wang Y, Jiao Z, Zhao K, Song K, Li Y, Shi W, Lu S. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024 Jul 15;9(1):182. doi: 10.1038/s41392-024-01897-y.

  PMID: 39004647 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study of SHR-A1811

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: April 23, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CN (1)