Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.

GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts.

GQ1001

Yan Shi

Charlotte Lemech, MD

Huan Zhou

Dianming Li

Shurong Zhang

Bo Yang

Yabing Guo

Jieqiong Liu

Yanqiu Zhao

Hong Zong

Kunyu Yang

Dongde Wu

Shanzhi Gu

Zhendong Li

Zhehai Wang

Yuping Sun

Wei Guo

Jia Fan

Huichuan Sun

Jun Zhang

Jin Li

Ye Guo

Xianbao Zhan

Caicun Zhou

Lei Liu

Lulu Liu

Meiyu Fang

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

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

A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors

Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.

The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.

Anti-GQ1001 antibody/anti-therapeutic antibody

GeneQuantum Healthcare (Suzhou) Co., Ltd.

Mouth and Tooth Diseases

Adenocarcinoma

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Oral Cancer

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients with Salivary Gland Carcinomas were given Surufatinib .

Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), A total of 2 cycles were performed, and efficacy evaluation was performed at the end of each cycle or was determined to be required by the investigator. If disease progression or unacceptable toxicity occurred during the period, induction therapy was terminated early, and after corresponding treatment, surgical treatment was entered as early as possible.

Surufatinib treatment was interrupted 4-7 days before surgical treatment to maintain organ function; Note: Postoperative radiotherapy or chemoradiotherapy is permitted after radical surgery at the discretion of the investigator.

Surufatinib

Min Ruan, MD

Shuyang Sun, MD

The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.

The purpose of this study was to explore whether the efficacy and survival time of patients with local advanced primary salivary gland adenocarcinoma could be further improved through the treatment of Surufatinib neoadjuvant for local advanced primary salivary gland adenocarcinoma, and to explore the safety and tolerability of this regimen.A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study.

Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas

A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study

CR + PR rate according to the RECIST version 1.1 guidelines.

the reduction of the active tumor below an established clinically significant node.

To assess the efficacy of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.

OS was calculated from the date of pharmacy to death from any cause.

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors	NCT04450732	HER2-positive B... HER2-positive B... HER2-Positive S... HER2-Positive A...	GQ1001	18 Years -	GeneQuantum Healthcare (Suzhou) Co., Ltd.
Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas	NCT05013515	Salivary Gland ...	Surufatinib	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas	NCT05013515	Salivary Gland ...	Surufatinib	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Spots Global Cancer Trial Database for salivary gland carcinomas