Locally Advanced or Metastatic Solid Tumors study: MRG007 vs MRG007 and Bevacizumab
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?
an investigational drug being studied as a potential treatment for unresectable 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
- The study aims to learn how safe and tolerable MRG007 is, how it behaves in the body, and whether it shows any anti‑cancer activity.
- Who it's for
- Adults who have unresectable locally advanced or metastatic solid tumors, including colorectal, gastric or pancreatic cancer.
- What's involved
- Participants will receive MRG007 by injection or infusion and will have regular clinic visits for safety checks, blood draws and imaging scans.
- Time commitment
- The trial runs for several months, with visits typically every few weeks to monitor side effects and tumor response.
- 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
- ≥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
- Additional protocol-defined exclusion criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- 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
- Zhengzhou, Henan, 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, but 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?
This study is enrolling now at 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 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.