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New drug MRG007 enters early human testing for Hard-to-Treat cancers

NCT ID NCT07066657

Disease control Sponsor: ArriVent BioPharma, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 5 times

Summary

This early-phase trial tests a new drug called MRG007 (ARR-217) in people with advanced solid tumors that have not responded to standard treatments. The study aims to find a safe dose and check if the drug can shrink tumors. About 405 participants with colorectal, gastric, or pancreatic cancer will take part across multiple centers.

What this could mean

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

Active substance
MRG007 (ARR-217)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors like colorectal, gastric, or pancreatic cancer.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. The drug may not shrink tumors or could cause serious side effects.

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

About 572 people

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

Started

Jul 2025

Expected to finish

Dec 2030

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 years and older

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.

1. Willing to sign the informed consent form and follow the requirements specified in the protocol. 2. Life expectancy ≥ 3 months. 3. Tumor specimen available for CDH17 testing, or agree to biopsy at baseline. 4. Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy. 5. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 6. The score of ECOG for performance status is 0 or 1. 7. Organ functions and coagulation function must meet the basic requirements. 8. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: 1. Patients with more than one cancer. 2. Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives, whichever is longer; investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose. 3. ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment 4. Symptomatic Central nervous system and/or meninges metastasis. 5. History of severe cardiovascular diseases 6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3 months prior to the first dose, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis 7. History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc. 8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion 9. Infection of active hepatitis B, active hepatitis C, or HIV 10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment 11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody. 12. Other situations that are not suitable to participate a clinical trial per investigator's judgement 13. Additional protocol-defined exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm malignant pancreatic neoplasm metastatic malignant neoplasm neoplasm pancreatic neoplasm

As listed by the trial registrant

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

Colorectal cancer Gastric cancer Locally advanced or metastatic solid tumors Pancreatic cancer

How to take part

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

  1. The places running it

    21 sites in 2 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

  • Beijing Gobroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102200, China

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Shandong, Jinan, 250000, China

  • Chongqing Daping Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400000, China

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Heilongjiang, Harbin, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sarah Cannon Research Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Zhejiang, Hangzhou, 310000, China

  • UCSF

    RECRUITING

    San Francisco, California, 94158, United States

  • ULCA

    RECRUITING

    Los Angeles, California, 90095, United States

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

    RECRUITING

    Wuhan, Hubei, China

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80010, United States

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

More trials for these conditions

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