NCT07066657RecruitingPhase 1
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 572 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- ArriVent BioPharma, Inc.
- NCT number
- NCT07066657
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 572
- From 25 Jul 2025 to the primary completion date, 31 Mar 2028
- 21 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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 illness
- Patients with more than one cancer.
- History of severe cardiovascular diseases
- Infection of active hepatitis B, active hepatitis C, or HIV
Lab values
- ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
Other
- Symptomatic Central nervous system and/or meninges metastasis.
- Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion
- Other situations that are not suitable to participate a clinical trial per investigator's judgement
- Additional protocol-defined exclusion criteria apply
Criteria the registry did not label
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Life expectancy ≥ 3 months.
- Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.
- Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- The score of ECOG for performance status is 0 or 1.
- Organ functions and coagulation function must meet the basic requirements.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing GoBroad Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Chongqing Daping Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Harbin medical university cancer hospital Coordinator of this site? Confirm its status | Heilongjiang | China | Recruiting |
| Cancer Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Shandong | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NEXT Dallas Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| ULCA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.