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Clinical Trials in the USA / NCT07066657
Recruiting Phase 1

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

NCT07066657 · tracked via the Priya Life Science USA tracker
Sponsor
ArriVent BioPharma, Inc.
Phase
Phase 1
Started
2025-07-25
Last updated
2026-08-13

Condition(s) studied

Locally Advanced or Metastatic Solid TumorsColorectal CancerGastric CancerPancreatic Cancer

Investigational drug(s) / intervention(s)

MRG007MRG007 and Bevacizumab

MRG007: MRG007 will be administrated as specified in the protocol.

MRG007 and Bevacizumab: MRG007 will be administered as specified in the protocol

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

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

More ArriVent BioPharma, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07066657 on ClinicalTrials.gov ↗ ← All trials in the USA