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

NCT07066657
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
572
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Lead sponsor
ArriVent BioPharma, Inc.
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Start date
2025-07-25
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Number of sites
21
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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.
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Short title
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-12-01
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First posted
2025-07-15
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Registry last updated
2026-08-13
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Primary completion date
2028-03-01
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Start date
2025-07-25
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Participants
572
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Participant count basis
Estimated
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Planned participants
572
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Protocol amendments
3
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Number of sites
21
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
ArriVent BioPharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07066657
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ClinicalTrials.gov ID
NCT07066657
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Limiting Toxicity (DLT) - Phase Ia

    Timeframe: Baseline to Day 21 of the first treatment cycle

  2. Serious Adverse Events (SAEs)

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

    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

  3. Treatment-Emergent Adverse Event (TEAE)

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

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

  4. Treatment-Related Adverse Event

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

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

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

    Timeframe: Baseline to study completion (up to 24 months)

    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.

  1. Objective Response Rate (ORR) - Phase Ia

    Timeframe: Baseline to study completion (up to 24 months)

    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.

  2. Disease Control Rate (DCR)

    Timeframe: Baseline to study completion (up to 24 months)

    DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.

  3. Duration of Response (DOR)

    Timeframe: Baseline to study completion (up to 24 months)

    The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.

  4. Progression Free Survival (PFS) as assessed by investigator

    Timeframe: Baseline to study completion (up to 24 months)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  5. Overall Survival (OS)

    Timeframe: Baseline to study completion (up to 24 months)

    OS is defined as the duration from the start of treatment to death of any cause.

  6. Incidence of anti-drug antibody (ADA)

    Timeframe: Baseline to 30 days after the last dose.

    The proportion of patients with positive ADA results.

  7. Incidence of neutralizing antibody (NAb)

    Timeframe: Baseline to 30 days after the last dose.

    The proportion of patients with positive NAb results.

  8. Tmax

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

    Time to reach the maximum blood concentration

  9. Cmax

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

    Maximum observed blood concentration

  10. AUC0-t

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

    Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration

  11. QTc interval

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

    Serum concentrations of MRG007, TAb, and unconjugated payload and change in QT interval corrected by Fridericia's formula (ΔQTcF) interval.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy 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.

  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 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.
  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
  13. Additional protocol-defined exclusion criteria apply
Sources for eligibility
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  • ULCALos Angeles, United StatesRecruiting
  • UCSFSan Francisco, United StatesRecruiting
  • University of ColoradoAurora, United StatesRecruiting
  • Sarah Cannon Research InstituteDenver, United StatesRecruiting
  • Sarah Cannon Research InstituteSarasota, United StatesRecruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • NEXT DallasIrving, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • Peking University Cancer HospitalBeijing, ChinaRecruiting
  • Beijing Gobroad HospitalBeijing, ChinaRecruiting
  • Chongqing Daping HospitalChongqing, ChinaRecruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of MedicineZhejiang, ChinaRecruiting
  • Harbin Medical University Cancer HospitalHeilongjiang, ChinaRecruiting
  • Henan Cancer HospitalZhengzhou, ChinaRecruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
  • Hunan Cancer HospitalChangsha, ChinaRecruiting
  • Cancer Hospital of Shandong First Medical UniversityShandong, ChinaRecruiting
  • Renji Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaRecruiting
  • Zhongshan Hospital Fudan UniversityShanghai, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (5)

Targets (1)