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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRG007

Group Type EXPERIMENTAL

MRG007

Intervention Type DRUG

MRG007 will be administrated as specified in the protocol.

Interventions

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MRG007

MRG007 will be administrated as specified in the protocol.

Intervention Type DRUG

Other Intervention Names

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ARR-217

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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