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

May 20, 2026 updated by: Shanghai Allink Biotherapeutics Co., Ltd.

A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Macquarie, Australia
        • Recruiting
        • Macquarie University Hospital
        • Contact:
          • Dr Andrew Parsonson
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Cancer Care Wollongong
        • Contact:
          • Dr. Udit Nindra
    • Queensland
      • Birtinya, Queensland, Australia
        • Recruiting
        • Sunshine Coast University Private Hospital
        • Contact:
          • Dr Michelle Morris
      • South Brisbane, Queensland, Australia
        • Recruiting
        • Mater Cancer Care Center
        • Contact:
          • Dr Catherine Shannon
  • China
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Yongsheng Li
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Yifu He
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Jianwei Yang
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Xiaoyan Lin
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Linli Chen
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Ruihua Xu
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Province People's Hospital
        • Contact:
          • Jian Xiao
      • Shantou, Guangdong, China
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
          • Yi Jiang
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Yongqiang Li
    • Hebei
      • Chengde, Hebei, China
        • Recruiting
        • Affiliated Hospital of Chengde Medical University
        • Contact:
          • Qingshan Li
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Canser Hospital
        • Contact:
          • Yanqiao Zhang
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
          • Shegan Gao, Ruinuo Jia
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Suxia Luo, Yanqiu Zhao
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College of HUST
        • Contact:
          • Xianglin Yuan
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Xinjun Liang
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
        • Contact:
          • Rui Meng
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer hospital
        • Contact:
          • Zhenyang Liu
      • Yongzhou, Hunan, China
        • Recruiting
        • The Central Hospital of Yongzhou
        • Contact:
          • Sijuan Ding
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • The First People's Hospital Of Changzhou
        • Contact:
          • Jun Wu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Yongmei Yin
      • Suzhou, Jiangsu, China
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
          • Zhixiang Zhuang
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )
        • Contact:
          • Liang Han
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Huaqiu Shi
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Jingdong Zhang
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Qi Dang, Xiaoyong Tang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Shanghai East Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Yan Zhang
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Lin Xie
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School Of Medicine
        • Contact:
          • Haiping Jiang, Jian Liu
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medical
        • Contact:
          • Yong Fang
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Denver Drug Development Unit
        • Contact:
          • Dr.Jason Henry
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • UCF Lake Nona Cancer Center
        • Contact:
          • Dr.Cesar Perez
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
          • Dr. Shou-Ching Tang
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute Oncology Partners
        • Contact:
          • Dr. Meredith Pelster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose-escalation Phase, Part B: Dose-expansion Phase

A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B).

A dose-expansion study which will enroll the select indications.
Drug: ALK201
Administered intravenously, once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
Time Frame: Approximately 36 months
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the pharmacokinetics (PK) of ALK201.
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Clearance(CL)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: terminal half-life (t1/2)
Approximately 36 months
To evaluate the immunogenicity of ALK201.
Time Frame: Approximately 36 months
The generation of anti-drug antibodies (ADAs).
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time Frame: Approximately 36 months
Objective Response Rate (ORR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time Frame: Approximately 36 months
Duration of Response (DOR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time Frame: Approximately 36 months
Disease Control Rate (DCR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time Frame: Approximately 36 months
Progression-Free Survival (PFS)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time Frame: Approximately 36 months
Overall Survival (OS)
Approximately 36 months
To evaluate the biomarkers.
Time Frame: Approximately 36 months
Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations.
Approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Allink Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

October 22, 2027

Study Completion (Estimated)

April 22, 2028

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK201-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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