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New treatment option for Locally Advanced or Metastatic Solid Tumors
Official title A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07066657
What this study is testing
What is MRG007?
MRG007 is an investigational medicine, being studied as a potential treatment for locally advanced or metastatic solid tumors.
Also referred to as ARR-217.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Life expectancy ≥ 3 months.
- Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.
- Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or...
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
You likely can't join 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...
- ≥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...
See the full eligibility criteria
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Life expectancy ≥ 3 months.
- Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.
- Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- The score of ECOG for performance status is 0 or 1.
- Organ functions and coagulation function must meet the basic requirements.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
- 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...
- ≥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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Zhejiang, Hangzhou, China
- Heilongjiang, Harbin, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Shandong, Jinan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; Sarasota, Florida, United States; Nashville, Tennessee, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.