Advanced CancerPhase 1/2NCT06656390
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing ALK201 in people with Advanced Cancer and Advanced Solid Tumors, run by Shanghai Allink Biotherapeutics Co., Ltd. at 38 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumors
- What is being tested?
- ALK201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 24 Oct 2024to 22 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 3 countries
China30 sites, 30 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Zhenyang Liu
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Jun Wu
- Recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei
Qingshan Li
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Yan Zhang
- Recruiting
ChongQing University Cancer Hospital
Chongqing
Yongsheng Li
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Jianwei Yang
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Xiaoyan Lin
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Huaqiu Shi
- Recruiting
Guangdong Province People's Hospital
Guangzhou, Guangdong
Jian Xiao
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Ruihua Xu
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang
Yong Fang
- Recruiting
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang
Haiping Jiang, Jian Liu
- Recruiting
Harbin Medical University Canser Hospital
Harbin, Heilongjiang
Yanqiao Zhang
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui
Yifu He
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong
Qi Dang, Xiaoyong Tang
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Lin Xie
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Shegan Gao, Ruinuo Jia
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Yongmei Yin
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Yongqiang Li
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Zhou fei, 86-021-38804818, story185@126.com
- Recruiting
Cancer Hospital Of Shantou University Medical College
Shantou, Guangdong
Yi Jiang
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Jingdong Zhang
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Zhixiang Zhuang
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Xinjun Liang
- Recruiting
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei
Xianglin Yuan
- Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei
Rui Meng
- Recruiting
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian
Linli Chen
- Recruiting
Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )
Xuzhou, Jiangsu
Liang Han
- Recruiting
The Central Hospital of Yongzhou
Yongzhou, Hunan
Sijuan Ding
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Suxia Luo, Yanqiu Zhao
United States4 sites, 4 recruiting
- Recruiting
Denver Drug Development Unit
Denver, Colorado, 80218
Dr.Jason Henry
- Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
Dr. Meredith Pelster
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Dr. Shou-Ching Tang
- Recruiting
UCF Lake Nona Cancer Center
Orlando, Florida, 32827
Dr.Cesar Perez
Australia4 sites, 4 recruiting
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland
Dr Michelle Morris
- Recruiting
Macquarie University Hospital
Macquarie
Dr Andrew Parsonson
- Recruiting
Mater Cancer Care Center
South Brisbane, Queensland
Dr Catherine Shannon
- Recruiting
Cancer Care Wollongong
Wollongong, New South Wales, 2500
Dr. Udit Nindra
About this study
Official title: 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.
- Conditions
- Advanced Cancer, Advanced Solid Tumors
- Being tested
- ALK201
- Keywords
- First-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK201Drug
Administered intravenously, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose-escalation Phase, Part B: Dose-expansion Phase | Experimental | 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. Receives: Drug: ALK201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Approximately 36 months
Secondary outcomes (16)
To evaluate the pharmacokinetics (PK) of ALK201.
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: Clearance(CL)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: terminal half-life (t1/2)
Measured: Approximately 36 months
To evaluate the immunogenicity of ALK201.
The generation of anti-drug antibodies (ADAs).
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Objective Response Rate (ORR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Duration of Response (DOR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Disease Control Rate (DCR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Progression-Free Survival (PFS)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Overall Survival (OS)
Measured: Approximately 36 months
To evaluate the biomarkers.
Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations.
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start24 Oct 2024
- Primary completion22 Oct 2027 (estimated)
- Study completion22 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656390
- Sponsor's protocol ID
- ALK201-01
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06656390
- Acronym / sponsor ID
- ALK201-01
- Conditions
- Advanced Cancer, Advanced Solid Tumors
- Keywords
- First-in-human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 22 Apr 2028 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose-escalation Phase, Part B: Dose-expansion Phase | Experimental | Drug: ALK201A 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALK201Administered intravenously, once every 3 weeks | Drug | Part A: Dose-escalation Phase, Part B: Dose-expansion Phase |
Primary outcome
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.
16 secondary outcomes
To evaluate the pharmacokinetics (PK) of ALK201.
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the immunogenicity of ALK201.
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the biomarkers.
Time frame: Approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALK201 in people with Advanced Cancer and Advanced Solid Tumors, run by Shanghai Allink Biotherapeutics Co., Ltd. at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALK Tang (+8618502921630, xftang@allinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.