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

Recruiting now · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT07066657

Run by

ArriVent BioPharma, Inc.

People needed

572

Starts

2025-07-25

Expected to finish

2030-12-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with more than one cancer.
• 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.
• ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
• Symptomatic Central nervous system and/or meninges metastasis.
• History of severe cardiovascular diseases
• 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
• 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.
• Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion
• Infection of active hepatitis B, active hepatitis C, or HIV
• Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment
• 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.
• Other situations that are not suitable to participate a clinical trial per investigator's judgement
• Additional protocol-defined exclusion criteria apply

Where it is running

• ULCA — Los Angeles, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Sarah Cannon Research Institute — Denver, Colorado, United States (enrolling)
• Sarah Cannon Research Institute — Sarasota, Florida, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Gobroad Hospital — Beijing, Beijing Municipality, China (enrolling)
• Army Medical Center of PLA — Chongqing, Chongqing Municipality, China (enrolling)
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Zhejiang, Hangzhou, China (enrolling)
• Harbin Medical University Cancer Hospital — Heilongjiang, Harbin, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Cancer Hospital of Shandong First Medical University — Shandong, Jinan, China (enrolling)
• Renji Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.