A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
Recruiting · NCT07066657 · Interventional (participants receive a specific treatment) · Lead sponsor: ArriVent BioPharma, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
MRG007MRG007 and Bevacizumab
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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
Where it is running
42 locations listed across 7 US states.
- ULCA - Los Angeles, California, United States
- ULCA - Los Angeles, California, United States
- UCSF - San Francisco, California, United States
- UCSF - San Francisco, California, United States
- University of Colorado - Aurora, Colorado, United States
- University of Colorado - Aurora, Colorado, United States
- Sarah Cannon Research Institute - Denver, Colorado, United States
- Sarah Cannon Research Institute - Denver, Colorado, United States
- Sarah Cannon Research Institute - Sarasota, Florida, United States
- Sarah Cannon Research Institute - Sarasota, Florida, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- NEXT Dallas - Irving, Texas, United States
- NEXT Dallas - Irving, Texas, United States
- NEXT Virginia - Fairfax, Virginia, United States
- NEXT Virginia - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Peking University Cancer Hospital - Beijing, Beijing Municipality, China
- Beijing Gobroad Hospital - Beijing, Beijing Municipality, China
- Peking University Cancer Hospital - Beijing, Beijing Municipality, China
- Beijing Gobroad Hospital - Beijing, Beijing Municipality, China
- Chongqing Daping Hospital - Chongqing, Chongqing Municipality, China
- Chongqing Daping Hospital - Chongqing, Chongqing Municipality, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Zhejiang, Hangzhou, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Zhejiang, Hangzhou, China
- Harbin Medical University Cancer Hospital - Heilongjiang, Harbin, China
- Harbin Medical University Cancer Hospital - Heilongjiang, Harbin, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Cancer Hospital of Shandong First Medical University - Shandong, Jinan, China
- Cancer Hospital of Shandong First Medical University - Shandong, Jinan, China
- Renji Hospital Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China
- Zhongshan Hospital Fudan University - Shanghai, Shanghai Municipality, China
- Renji Hospital Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China
- Zhongshan Hospital Fudan University - Shanghai, Shanghai Municipality, China