Back to Trials
NCT07066657PHASE1Recruiting

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors

ArriVent BioPharma, Inc.

Start Date

7/25/2025

Completion Date

12/1/2030

Summary

This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

MRG007

DRUG

MRG007 and Bevacizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Locally Advanced or Metastatic Solid TumorsColorectal CancerGastric CancerPancreatic Cancer

Locations

ULCA

Los Angeles, California 90095

United States

UCSF

San Francisco, California 94158

United States

University of Colorado

Aurora, Colorado 80010

United States

Sarah Cannon Research Institute

Denver, Colorado 80218

United States

Sarah Cannon Research Institute

Sarasota, Florida 34232

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Dallas

Irving, Texas 75039

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Peking University Cancer Hospital

Beijing, Beijing Municipality 100142

China

Beijing Gobroad Hospital

Beijing, Beijing Municipality 102200

China

Army Medical Center of PLA

Chongqing, Chongqing Municipality 400000

China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Zhejiang, Hangzhou 310000

China

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin 150000

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

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

Wuhan, Hubei

China

Hunan Cancer Hospital

Changsha, Hunan

China

Cancer Hospital of Shandong First Medical University

Shandong, Jinan 250000

China

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality

China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality

China