Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

Summary

Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors

Timeline

Start

2020-07-07

Primary completion

2024-03-01

Completion

2024-05-01

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary endpoints were safety and to determine the maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs). PMID 39789619 ↗

paper No DLT was observed during dose escalation. MTD was not reached PMID 39789619 ↗

Publications

• Zhou C, Wang B, Teng C, Yang H, Piha-Paul SA, Richardson G, Malalasekera A, Sun Y, Wang W, Liu J, Shi Y, Zhan X, Lemech C. A phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001 in patients with previously treated HER2 positive advanced solid tumors. J Transl Med. 2025 Jan 9;23(1):37. doi: 10.1186/s12967-024-05985-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GQ1001	Other / unclassified	1.2 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	2.4 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	3.6 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	4.8 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	6 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	7.2 mg/kg	Intravenous
Subject	GQ1001	Other / unclassified	8.4 mg/kg	Intravenous

Indications