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Experimental drug SHR-A2009 takes first steps against Hard-to-Treat cancers

NCT ID NCT05114759

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental drug called SHR-A2009 in people with advanced solid tumors that have stopped responding to standard treatments or have no standard options. The main goals are to find a safe dose and to understand the drug's side effects and how the body processes it. The study will also look for early signs that the drug might shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called SHR-A2009
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have few alternatives.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, so it is unknown if SHR-A2009 will effectively shrink tumors or improve survival. Side effects are also not yet fully understood.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

176 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Dec 2026

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 70 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: 1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage); 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function . 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. Exclusion Criteria: 1. Patients with symptomatic central nervous system metastases or meningeal metastases; 2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors; 4. History of serious cardiovascular and cerebrovascular diseases; 5. Severe infection within 4 weeks prior to the first dose; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Chongqing Cancer Hospital

    Chongqicun, Chongqi, 400000, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350000, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000, China

  • National Cancer Center Hospital

    Tokyo, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Chiba, 277-8577, Japan

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

  • Shandong Cancer Hospital&Institute

    Jinan, Shandong, 250000, China

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610000, China

  • The First Hospital of JiLin University

    Changchun, Jlin, 132000, China

  • The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

    Xi’an, Shanxi, 710000, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000, China

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610000, China

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