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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Cancer, Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06656390

Run by

Shanghai Allink Biotherapeutics Co., Ltd.

People needed

202

Starts

2024-10-24

Expected to finish

2028-04-22

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Denver Drug Development Unit — Denver, Colorado, United States (enrolling)
• UCF Lake Nona Cancer Center — Orlando, Florida, United States (enrolling)
• University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)
• Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Cancer Care Wollongong — Wollongong, New South Wales, Australia (enrolling)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (enrolling)
• Mater Cancer Care Center — South Brisbane, Queensland, Australia (enrolling)
• Macquarie University Hospital — Macquarie, Australia (enrolling)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital Of Xiamen University — Xiamen, Fujian, China (enrolling)
• Guangdong Province People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Cancer Hospital Of Shantou University Medical College — Shantou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (enrolling)
• Harbin Medical University Canser Hospital — Harbin, Heilongjiang, China (enrolling)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Tongji Hospital, Tongji Medical College of Hust — Wuhan, Hubei, China (enrolling)
• Union Hospital, Tongji Medical College,Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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