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

NCT07066657 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MRG007-001/ARR-217-101
• Study Type: interventional
• Target: 405
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors; Colorectal Cancer; Gastric Cancer; Pancreatic Cancer

Keywords

MRG007; Advanced or Metastatic Solid Tumors; CDH17; ARR-217; ADC

Outcome Measures

Primary Outcomes (5)

• Dose Limiting Toxicity (DLT) - Phase Ia

  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

  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

  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.

  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.

  Baseline to study completion (up to 24 months)

Secondary Outcomes (10)

• Objective Response Rate (ORR) - Phase Ia

  Baseline to study completion (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Duration of Response (DOR)

  Baseline to study completion (up to 24 months)

• Progression Free Survival (PFS) as assessed by investigator

  Baseline to study completion (up to 24 months)

• Overall Survival (OS)

  Baseline to study completion (up to 24 months)

Study Arms (1)

MRG007

EXPERIMENTAL

Drug: MRG007

Interventions

MRG007 DRUG

MRG007 will be administrated as specified in the protocol.

Also known as: ARR-217

MRG007

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with more than one cancer.
• 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.
• ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
• Symptomatic Central nervous system and/or meninges metastasis.
• History of severe cardiovascular diseases
• 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.
• Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion
• Infection of active hepatitis B, active hepatitis C, or HIV
• 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 situations that are not suitable to participate a clinical trial per investigator's judgement

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: collaborator
• ArriVent BioPharma, Inc.: lead

Study Sites (15)

ULCA

Los Angeles, California, 90095, United States

NOT YET RECRUITING

UCSF

San Francisco, California, 94158, United States

NOT YET RECRUITING

University of Colorado

Aurora, Colorado, 80010, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Sarasota, Florida, 34232, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

NOT YET RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

ACTIVE NOT RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

ACTIVE NOT RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@lepubiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 15, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5); US (10)