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RecruitingInterventionalPhase 1

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

NCT ID: NCT07066657Sponsor: ArriVent BioPharma, Inc.Last updated: 2026-06-04

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.

Arms & interventions

  • DrugMRG007

    MRG007 will be administrated as specified in the protocol.

Outcome measures

Primary

  • Dose Limiting Toxicity (DLT) - Phase Ia

    Time frame: Baseline to Day 21 of the first treatment cycle

  • Serious Adverse Events (SAEs)

    Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions

    Time frame: Baseline to 30 days after the last dose of study treatment

  • Treatment-Emergent Adverse Event (TEAE)

    AEs that occur or worsen on or after the first dose of study treatment

    Time frame: Baseline to 30 days after the last dose of study treatment

  • Treatment-Related Adverse Event

    Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.

    Time frame: Baseline to 30 days after the last dose of study treatment

  • Objective Response Rate (ORR) as assessed by investigator - Phase Ib

    ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.

    Time frame: Baseline to study completion (up to 24 months)

Secondary

  • Objective Response Rate (ORR) - Phase Ia

    Time frame: Baseline to study completion (up to 24 months)

  • Disease Control Rate (DCR)

    Time frame: Baseline to study completion (up to 24 months)

  • Duration of Response (DOR)

    Time frame: Baseline to study completion (up to 24 months)

  • Progression Free Survival (PFS) as assessed by investigator

    Time frame: Baseline to study completion (up to 24 months)

  • Overall Survival (OS)

    Time frame: Baseline to study completion (up to 24 months)

  • Incidence of anti-drug antibody (ADA)

    Time frame: Baseline to 30 days after the last dose.

  • Incidence of neutralizing antibody (NAb)

    Time frame: Baseline to 30 days after the last dose.

  • Tmax

    Time frame: Baseline to 30 days after the last dose of study treatment

  • Cmax

    Time frame: Baseline to 30 days after the last dose of study treatment

  • AUC0-t

    Time frame: Baseline to 30 days after the last dose of study treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 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 locations (10)

ULCA

Los Angeles, California, 90095

Recruiting

UCSF

San Francisco, California, 94158

Not Yet Recruiting

University of Colorado

Aurora, Colorado, 80010

Recruiting

Sarah Cannon Research Institute

Denver, Colorado, 80218

Recruiting

Sarah Cannon Research Institute

Sarasota, Florida, 34232

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

NEXT Dallas

Irving, Texas, 75039

Recruiting

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

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