Actively Recruiting
Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors
Led by ArriVent BioPharma, Inc. · Updated on 2026-06-04
405
Participants Needed
20
Research Sites
82 weeks
Total Duration
On this page
Sponsors
A
ArriVent BioPharma, Inc.
Lead Sponsor
L
Lepu Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MRG007 (ARR-217) in an open-label, multi-center phase I clinical trial involving patients with unresectable locally advanced or metastatic solid tumors, including colorectal, gastric, and pancreatic cancers. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of MRG007 in patients who have failed or are intolerant to standard therapies or have no alternative treatment options. Participants will receive MRG007 as specified in the study protocol. The trial includes dose escalation, confirmation, and expansion phases to evaluate different dosing levels and effects. Treatments will be administered and monitored accordingly, with assessments continuing up to 24 months or longer for long-term evaluation. During the study, participants will undergo regular evaluations including tumor measurements, safety monitoring for adverse events, laboratory tests, and pharmacokinetic sampling. Researchers will observe dose limiting toxicities, adverse events, and treatment responses using standardized criteria. Follow-up will continue for 30 days after the last dose to monitor safety and immune response. Overall study participation may last up to two years, with ongoing assessments to understand treatment impact and patient outcomes.
CONDITIONS
Brief Title
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent form and follow the protocol requirements.
- Life expectancy of at least 3 months.
- Tumor specimen available for CDH17 testing or agree to biopsy at baseline.
- Histologically and cytologically confirmed advanced or metastatic solid tumor with failure or intolerance to standard therapy, or no alternative standard therapy.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status score of 0 or 1.
- Organ and coagulation functions meeting basic requirements.
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential.
You will not qualify if you...
- Having more than one type of cancer.
- Prior CDH17-targeting anti-tumor therapy or investigational product, systemic corticosteroids, or major organ surgery within 4 weeks before first dose.
- Anti-tumor therapy within 3 weeks or 5 half-lives before first dose, whichever is shorter.
- Radiotherapy within 2 weeks before first dose.
- Use of potent CYP3A4 inducers or inhibitors within 2 weeks before first dose or 5 half-lives of investigational product.
- Grade 2 or higher toxic reaction or abnormal lab value from previous anti-tumor treatment.
- Symptomatic central nervous system or meninges metastasis.
- History of severe cardiovascular diseases.
- Recent cerebrovascular accident, pulmonary embolism, deep venous thrombosis, or catheter-related thrombosis.
- History or suspected interstitial pneumonia or severe pulmonary conditions.
- Poorly controlled pleural, peritoneal, pelvic, or pericardial effusion.
- Active hepatitis B, hepatitis C, or HIV infection.
- Uncontrolled active infections requiring intravenous therapy within 2 weeks before first dose.
- Known allergies to MRG007 components or severe allergic reactions to prior anti-CDH17 or other monoclonal antibodies.
- Other conditions deemed unsuitable for clinical trial participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive MRG007 as specified in the protocol to evaluate safety, tolerability, and efficacy.
Regular visits during treatment period (specific schedule as per protocol)
Duration - 30 days after the last dose
Participants are monitored for safety and adverse events after the last dose of MRG007.
Approximately 1 to 2 visits
Trial Site Locations
Total: 20 locations
1
ULCA
Los Angeles, California, United States, 90095
Actively Recruiting
2
UCSF
San Francisco, California, United States, 94158
Not Yet Recruiting
3
University of Colorado
Aurora, Colorado, United States, 80010
Actively Recruiting
4
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
Actively Recruiting
5
Sarah Cannon Research Institute
Sarasota, Florida, United States, 34232
Actively Recruiting
6
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
9
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
11
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
12
Beijing Gobroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
13
Army Medical Center of PLA
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
14
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, China, 310000
Actively Recruiting
15
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China, 150000
Actively Recruiting
16
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
17
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
18
Cancer Hospital of Shandong First Medical University
Shandong, Jinan, China, 250000
Actively Recruiting
19
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
P
Priya Wason
P
Program Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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