> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mrg007-arr-217-in-patients-with-advanced-solid-e7db05dd-80f9-4b4f-b346-eee86c925a71 > Record changed: 2026-10-13 # A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors NCT07066657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Participants 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Lead sponsor ArriVent BioPharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Start date 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) Number of sites 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Short title** A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Dates **Completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **First posted** 2025-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Registry last updated** 2026-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Primary completion date** 2028-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Start date** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Size and sites **Participants** 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Planned participants** 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Number of sites** 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Lead sponsor** ArriVent BioPharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Identifiers **Registry ID** NCT07066657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **ClinicalTrials.gov ID** NCT07066657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Outcomes ### Primary outcomes 1. Dose Limiting Toxicity (DLT) - Phase Ia Timeframe: Baseline to Day 21 of the first treatment cycle 2. Serious Adverse Events (SAEs) Timeframe: Baseline to 30 days after the last dose of study treatment Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions 3. Treatment-Emergent Adverse Event (TEAE) Timeframe: Baseline to 30 days after the last dose of study treatment AEs that occur or worsen on or after the first dose of study treatment 4. Treatment-Related Adverse Event Timeframe: Baseline to 30 days after the last dose of study treatment Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug. 5. Objective Response Rate (ORR) as assessed by investigator - Phase Ib Timeframe: Baseline to study completion (up to 24 months) ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1. ### Secondary outcomes 1. Objective Response Rate (ORR) - Phase Ia Timeframe: Baseline to study completion (up to 24 months) ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1. 2. Disease Control Rate (DCR) Timeframe: Baseline to study completion (up to 24 months) DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment. 3. Duration of Response (DOR) Timeframe: Baseline to study completion (up to 24 months) The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier. 4. Progression Free Survival (PFS) as assessed by investigator Timeframe: Baseline to study completion (up to 24 months) PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. 5. Overall Survival (OS) Timeframe: Baseline to study completion (up to 24 months) OS is defined as the duration from the start of treatment to death of any cause. 6. Incidence of anti-drug antibody (ADA) Timeframe: Baseline to 30 days after the last dose. The proportion of patients with positive ADA results. 7. Incidence of neutralizing antibody (NAb) Timeframe: Baseline to 30 days after the last dose. The proportion of patients with positive NAb results. 8. Tmax Timeframe: Baseline to 30 days after the last dose of study treatment Time to reach the maximum blood concentration 9. Cmax Timeframe: Baseline to 30 days after the last dose of study treatment Maximum observed blood concentration 10. AUC0-t Timeframe: Baseline to 30 days after the last dose of study treatment Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration 11. QTc interval Timeframe: Baseline to 30 days after the last dose of study treatment Serum concentrations of MRG007, TAb, and unconjugated payload and change in QT interval corrected by Fridericia's formula (ΔQTcF) interval. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Sites - ULCALos Angeles, United StatesRecruiting - UCSFSan Francisco, United StatesRecruiting - University of ColoradoAurora, United StatesRecruiting - Sarah Cannon Research InstituteDenver, United StatesRecruiting - Sarah Cannon Research InstituteSarasota, United StatesRecruiting - Sarah Cannon Research InstituteNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - NEXT DallasIrving, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Peking University Cancer HospitalBeijing, ChinaRecruiting - Beijing Gobroad HospitalBeijing, ChinaRecruiting - Chongqing Daping HospitalChongqing, ChinaRecruiting - Sir Run Run Shaw Hospital, Zhejiang University School of MedicineZhejiang, ChinaRecruiting - Harbin Medical University Cancer HospitalHeilongjiang, ChinaRecruiting - Henan Cancer HospitalZhengzhou, ChinaRecruiting - Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting - Hunan Cancer HospitalChangsha, ChinaRecruiting - Cancer Hospital of Shandong First Medical UniversityShandong, ChinaRecruiting - Renji Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaRecruiting - Zhongshan Hospital Fudan UniversityShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066657) ## Related records ### Drugs (1) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) ### Collaborators (1) - Lepu Biopharma Co., Ltd. ### Lead sponsors (1) - [ArriVent BioPharma, Inc.](https://trialight.com/data/company/arrivent-biopharma-inc-a1c62122-e234-44d3-9bc1-ccfabc57145a.md) ### Conditions (5) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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