A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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. 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 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
Study sites (10)
CA
- ULCA · Los Angeles, CA 90095More trials in Los Angeles
- UCSF · San Francisco, CA 94158More trials in San Francisco
CO
- University of Colorado · Aurora, CO 80010More trials in Aurora
- Sarah Cannon Research Institute · Denver, CO 80218More trials in Denver
FL
- Sarah Cannon Research Institute · Sarasota, FL 34232More trials in Sarasota
TN
- Sarah Cannon Research Institute · Nashville, TN 37203More trials in Nashville
TX
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- NEXT Dallas · Irving, TX 75039More trials in Irving
VA
- NEXT Virginia · Fairfax, VA 22031More trials in Fairfax
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109More trials in Seattle