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A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
NCT07066657 · ArriVent BioPharma, Inc.
In plain English
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Official title
An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
About this study
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
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 potent CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives of investigational product, whichever is longer.
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
Study design
Enrollment target: 405 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-25
Estimated completion: 2030-12
Last updated: 2026-02-17
Interventions
Drug: MRG007
Primary outcomes
- • Dose Limiting Toxicity (DLT) - Phase Ia (Baseline to Day 21 of the first treatment cycle)
- • Serious Adverse Events (SAEs) (Baseline to 30 days after the last dose of study treatment)
- • Treatment-Emergent Adverse Event (TEAE) (Baseline to 30 days after the last dose of study treatment)
Sponsor
ArriVent BioPharma, Inc. · industry
With: Lepu Biopharma Co., Ltd.
Contacts & investigators
ContactProgram Director · contact · clinicaltrials@lepubiopharma.com · 86-21-61637960
All locations (15)
ULCANot Yet Recruiting
Los Angeles, California, United States
UCSFNot Yet Recruiting
San Francisco, California, United States
University of ColoradoNot Yet Recruiting
Aurora, Colorado, United States
Sarah Cannon Research InstituteNot Yet Recruiting
Denver, Colorado, United States
Sarah Cannon Research InstituteNot Yet Recruiting
Sarasota, Florida, United States
Sarah Cannon Research InstituteNot Yet Recruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
NEXT DallasNot Yet Recruiting
Irving, Texas, United States
NEXT VirginiaNot Yet Recruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterNot Yet Recruiting
Seattle, Washington, United States
Peking University Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyActive Not Recruiting
Wuhan, Hubei, China
Hunan Cancer HospitalActive Not Recruiting
Changsha, Hunan, China
Renji Hospital Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China