A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

NCT04446260 | Completed Phase 1 FDA Drug

• 1 other identifier: SHR-A1811-I-101
• Study Type: interventional
• Target: 396
• Locations: 5 countries
• Sites: 35

Brief Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  Frequency and seriousness of treatment emergent adverse events (TEAEs)

  From Day1 to 90 days after last dose

Secondary Outcomes (5)

• PK parameter: Tmax of SHR-A1811

  Through study completion, an average of 1 year

• PK parameter: Cmax of SHR-A1811

  Through study completion, an average of 1 year

• PK parameter: AUC0-t of SHR-A1811

  Through study completion, an average of 1 year

• Immunogenicity of SHR-A1811

  Through study completion, an average of 1 year

• Tumor response using RECIST 1.1

  From first dose to disease progression or death, whichever comes first, up to 30 months

Study Arms (3)

Part 1 Dose escalation

EXPERIMENTAL

Drug: SHR-A1811

Part 2 PK expansion

EXPERIMENTAL

Drug: SHR-A1811

Part 3 Indication expansion

EXPERIMENTAL

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

be administered via intravenous (IV) infusion

Part 1 Dose escalation; Part 2 PK expansion; Part 3 Indication expansion

Eligibility Criteria

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

You may qualify if:

• Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• LVEF ≥ 50% by either ECHO or MUGA
• Has adequate renal and hepatic function
• Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

You may not qualify if:

• History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
• Known hereditary or acquired bleeding and thrombotic tendency

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Atridia Pty Ltd.: collaborator

Study Sites (35)

Montefiore-Einstein Center for Cancer Care

The Bronx, New York, 10461, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

Macquarie University Hospital

Macquarie, New South Wales, 2109, Australia

Location

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5042, Australia

Location

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Alfred Hospital

Melbourne, 3004, Australia

Location

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233000, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Fujian Cancer Hospital

Fujian, Fuzhou, 350000, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510120, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Henan cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Zhongnan hospital of Wuhan university

Wuhan, Hubei, 430062, China

Location

Hubei cancer hospital

Wuhan, Hubei, 430079, China

Location

Xiangya hospital central south university

Changsha, Hunan, 410008, China

Location

Hunan cancer hospital

Changsha, Hunan, 410031, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Shengjing Hospital of China medical university

Shengyang, Liaoning, 110022, China

Location

Fudan University Shanghai cancer center

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan Unversity Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Jiao Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610042, China

Location

Tianjin medical university cancer institute&hoospital

Tianjin, Tianjin Municipality, 300181, China

Location

The second affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, 310014, China

Location

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70457, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Yao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20.

  PMID: 38900984 DERIVED

Study Design

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

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 24, 2020
• Study Start: September 7, 2020
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: September 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3); KR (3); CN (21); AU (5); US (3)