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MRG007 (ARR-217) treatment for 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

Phase 1 Interventional ArriVent BioPharma, Inc. · NCT07066657

This trial will test MRG007 (ARR-217), an antibody-drug conjugate that targets CDH17, in adults with unresectable locally advanced or metastatic solid tumors who have exhausted standard therapies.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment405 (estimated)
Ages18 Years and up
SexAll
SponsorArriVent BioPharma, Inc. Industry-sponsored
Locations15 sites (Los Angeles, California and 14 other locations)
Trial IDNCT07066657 on ClinicalTrials.gov

What this trial studies

This is an open-label, multi-center Phase 1 trial of MRG007 (ARR-217) designed to define safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced or metastatic solid tumors. The investigational drug is an antibody-drug conjugate directed at CDH17 and requires tumor tissue for CDH17 testing or a baseline biopsy. Eligible patients have measurable disease by RECIST v1.1, ECOG performance status 0-1, and have failed or are intolerant of standard therapy; dosing and assessments will follow a standard early-phase escalation and expansion design. Sites include academic centers at UCLA, UCSF, and the University of Colorado and will involve regular on-site visits for treatment and monitoring.

Who should consider this trial

Good fit: Adults with unresectable locally advanced or metastatic solid tumors (including colorectal, gastric, and pancreatic cancers) who have progressed on or are intolerant to standard treatments, have measurable disease, ECOG 0-1, and available tumor tissue for CDH17 testing are the ideal candidates.

Not a fit: Patients whose tumors do not express CDH17, who have poor performance status (ECOG >1), multiple active cancers, prior CDH17-targeting therapy, or life expectancy under three months are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, MRG007 could provide a new targeted therapy option for patients with CDH17-positive advanced gastrointestinal and other solid tumors.

How similar studies have performed: While antibody-drug conjugates have shown clinical success in other tumor targets, CDH17-directed therapies are novel and have limited prior clinical evidence to date.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic Solid TumorsColorectal CancerGastric CancerPancreatic CancerMRG007Advanced or Metastatic Solid TumorsCDH17ARR-217
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.