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NCT06656390PHASE1, PHASE2Recruiting

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

Shanghai Allink Biotherapeutics Co., Ltd.

Start Date

10/24/2024

Completion Date

4/22/2028

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 Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

ALK201

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Conditions

Advanced CancerAdvanced Solid Tumors

Locations

Denver Drug Development Unit

Denver, Colorado 80218

United States

UCF Lake Nona Cancer Center

Orlando, Florida 32827

United States

University Medical Center New Orleans

New Orleans, Louisiana 70112

United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee 37203

United States

Cancer Care Wollongong

Wollongong, New South Wales 2500

Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland

Australia

Mater Cancer Care Center

South Brisbane, Queensland

Australia

Macquarie University Hospital

Macquarie,

Australia

Anhui Provincial Cancer Hospital

Hefei, Anhui

China

Fujian Cancer Hospital

Fuzhou, Fujian

China

Fujian Medical University Union Hospital

Fuzhou, Fujian

China

The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian

China

Guangdong Province People's Hospital

Guangzhou, Guangdong

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong

China

Cancer Hospital Of Shantou University Medical College

Shantou, Guangdong

China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi

China

Affiliated Hospital of Chengde Medical University

Chengde, Hebei

China

Harbin Medical University Canser Hospital

Harbin, Heilongjiang

China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan

China

Henan Cancer Hospital

Zhengzhou, Henan

China

Hubei Cancer Hospital

Wuhan, Hubei

China

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei

China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei

China

Hunan Cancer Hospital

Changsha, Hunan

China

The Central Hospital of Yongzhou

Yongzhou, Hunan

China

The First People's Hospital of Changzhou

Changzhou, Jiangsu

China

Jiangsu Province Hospital

Nanjing, Jiangsu

China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu

China

Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )

Xuzhou, Jiangsu

China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi

China

Liaoning Cancer Hospital

Shenyang, Liaoning

China

Shandong Cancer Hospital

Jinan, Shandong

China

Shanghai East Hospital

Shanghai, Shanghai Municipality 200000

China

West China Hospital of Sichuan University

Chengdu, Sichuan

China

Yunnan Cancer Hospital

Kunming, Yunnan

China

Sir Run Run Shaw Hospital Zhejiang University School of Medical

Hangzhou, Zhejiang

China

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang

China

ChongQing University Cancer Hospital

Chongqing,

China