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Clinical Trials in the USA / NCT06656390
Recruiting Phase 1/2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

NCT06656390 · tracked via the Priya Life Science USA tracker
Sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
Phase
Phase 1/2
Started
2024-10-24
Last updated
2026-05-22

Condition(s) studied

Advanced CancerAdvanced Solid Tumors

Investigational drug(s) / intervention(s)

ALK201

ALK201: Administered intravenously, once every 3 weeks

Study summary

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Men and women ≥18 and ≤75 years old on the day of signing the ICF * At least 1 measurable lesion per RECIST v1.1 * Expected survival ≥3 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 * Adequate organ function * Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms Exclusion Criteria: * Active or pre-existing autoimmune diseases that may relapse * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage * Allergies to any component of ALK201 or other monoclonal antibodies * Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening * Vaccinated with live vaccines within 4 weeks prior to the first dose Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Denver Drug Development Unit Denver Colorado Recruiting
UCF Lake Nona Cancer Center Orlando Florida Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
Sarah Cannon Research Institute Oncology Partners Nashville Tennessee Recruiting
Cancer Care Wollongong Wollongong New South Wales Recruiting
Sunshine Coast University Private Hospital Birtinya Queensland Recruiting
Mater Cancer Care Center South Brisbane Queensland Recruiting
Macquarie University Hospital Macquarie Australia Recruiting
Anhui Provincial Cancer Hospital Hefei Anhui Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital Of Xiamen University Xiamen Fujian Recruiting
Guangdong Province People's Hospital Guangzhou Guangdong Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Cancer Hospital Of Shantou University Medical College Shantou Guangdong Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
Affiliated Hospital of Chengde Medical University Chengde Hebei Recruiting
Harbin Medical University Canser Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Hospital, Tongji Medical College of Hust Wuhan Hubei Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
The Central Hospital of Yongzhou Yongzhou Hunan Recruiting
The First People's Hospital of Changzhou Changzhou Jiangsu Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Xuzhou Central Hospital ( Southeast University Affiliated Hopstal ) Xuzhou Jiangsu Recruiting
First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Yunnan Cancer Hospital Kunming Yunnan Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medical Hangzhou Zhejiang Recruiting
The First Affiliated Hospital Zhejiang University School Of Medicine Hangzhou Zhejiang Recruiting
ChongQing University Cancer Hospital Chongqing China Recruiting

More Shanghai Allink Biotherapeutics Co., Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656390 on ClinicalTrials.gov ↗ ← All trials in the USA