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New hope for advanced cancer: first human trial of ALK201 begins

NCT ID NCT06656390

Disease control Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, ALK201, for the first time in people with advanced solid tumors that have not responded to other treatments. The goal is to find a safe dose and see if the drug can shrink tumors. About 202 adults aged 18 to 75 will take part. The study is currently recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Chengde Medical University

    RECRUITING

    Chengde, Hebei, China

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, Anhui, China

  • Cancer Care Wollongong

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Cancer Hospital Of Shantou University Medical College

    RECRUITING

    Shantou, Guangdong, China

  • ChongQing University Cancer Hospital

    RECRUITING

    Chongqing, China

  • Denver Drug Development Unit

    RECRUITING

    Denver, Colorado, 80218, United States

  • First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Ganzhou, Jiangxi, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Province People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Harbin Medical University Canser Hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, China

  • Macquarie University Hospital

    RECRUITING

    Macquarie, Australia

  • Mater Cancer Care Center

    RECRUITING

    South Brisbane, Queensland, Australia

  • Sarah Cannon Research Institute Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medical

    RECRUITING

    Hangzhou, Zhejiang, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, Australia

  • The Central Hospital of Yongzhou

    RECRUITING

    Yongzhou, Hunan, China

  • The First Affiliated Hospital Of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    RECRUITING

    Luoyang, Henan, China

  • The First People's Hospital of Changzhou

    RECRUITING

    Changzhou, Jiangsu, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Tongji Hospital, Tongji Medical College of Hust

    RECRUITING

    Wuhan, Hubei, China

  • UCF Lake Nona Cancer Center

    RECRUITING

    Orlando, Florida, 32827, United States

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

    RECRUITING

    Wuhan, Hubei, China

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )

    RECRUITING

    Xuzhou, Jiangsu, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.