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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 | Experimental | SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1：PK parameter ：Tmax of SHRA1811 | Time to maximal concentration (Tmax) of SHR-A1811 | appropriately to 3 years |
| Phase1:PK parameter: Cmax of SHR-A1811 | Maximal concentration (Cmax) of SHR-A1811 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40020696 | Derived | 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. | |
| 39004647 |
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Single arm study of SHR-A1811
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| appropriately to 3 years |
| 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 |
| 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 |
| Phase2:Progression Free Survival (PFS) | As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator | appropriately to 3 years |
| Phase2:ObjectiveResponse Rate (ORR) | As assessed by RECIST v1.1 , as assessed by investigator | appropriately to 3 years |
| Phase2:Duration of response (DOR) | As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator | appropriately to 3 years |
| Phase2:Disease control rate (DCR) | As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator | appropriately to 3 years |
| Phase2:Overall survival (OS) | Approximately 5 years after last subject enrolled |
| 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. |