Locally Advanced or Metastatic Solid TumorsPhase 1NCT07066657
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
A Phase 1 study testing MRG007 and MRG007 and Bevacizumab in people with Locally Advanced or Metastatic Solid Tumors and Colorectal Cancer, run by ArriVent BioPharma, Inc. at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer
- What is being tested?
- MRG007 and MRG007 and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 25 Jul 2025to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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; 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.
- ≥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
Show all 13Show fewer
- 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.
- 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
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
China11 sites, 11 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, M.D., 86-10-88196561, doctorshenlin@sina.cn
- Recruiting
Beijing Gobroad Hospital
Beijing, Beijing Municipality, 102200
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Zhenyang Liu
- Recruiting
Chongqing Daping Hospital
Chongqing, Chongqing Municipality, 400000
- Recruiting
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, 150000
- Recruiting
Cancer Hospital of Shandong First Medical University
Shandong, Jinan, 250000
- Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xiuying Xiao
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
Tianshu Liu
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tao Zhang
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310000
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
United States10 sites, 10 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80010
- Recruiting
Sarah Cannon Research Institute
Denver, Colorado, 80218
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Dallas
Irving, Texas, 75039
- Recruiting
ULCA
Los Angeles, California, 90095
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
UCSF
San Francisco, California, 94158
- Recruiting
Sarah Cannon Research Institute
Sarasota, Florida, 34232
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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
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.
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Being tested
- MRG007, MRG007 and Bevacizumab
- Keywords
- MRG007, Advanced or Metastatic Solid Tumors, CDH17, ARR-217, ADC
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG007Drug
Also called ARR-217
MRG007 will be administrated as specified in the protocol.
MRG007 and BevacizumabDrug
Also called ARR-217
MRG007 will be administered as specified in the protocol
| Study group | Role | What they receive |
|---|---|---|
| MRG007 | Experimental | Not described Receives: Drug: MRG007 |
| MRG007 and Bevacizumab | Experimental | Not described Receives: Drug: MRG007 and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) - Phase Ia
Measured: Baseline to Day 21 of the first treatment cycle
Serious Adverse Events (SAEs)
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
Measured: Baseline to 30 days after the last dose of study treatment
Treatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Measured: Baseline to 30 days after the last dose of study treatment
Treatment-Related Adverse Event
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.
Measured: Baseline to 30 days after the last dose of study treatment
Objective Response Rate (ORR) as assessed by investigator - Phase Ib
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.
Measured: Baseline to study completion (up to 24 months)
Secondary outcomes (11)
Objective Response Rate (ORR) - Phase Ia
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.
Measured: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
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.
Measured: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 24 months)
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
Measured: Baseline to 30 days after the last dose.
Incidence of neutralizing antibody (NAb)
The proportion of patients with positive NAb results.
Measured: Baseline to 30 days after the last dose.
Tmax
Time to reach the maximum blood concentration
Measured: Baseline to 30 days after the last dose of study treatment
Cmax
Maximum observed blood concentration
Measured: Baseline to 30 days after the last dose of study treatment
AUC0-t
Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration
Measured: Baseline to 30 days after the last dose of study treatment
QTc interval
Serum concentrations of MRG007, TAb, and unconjugated payload and change in QT interval corrected by Fridericia's formula (ΔQTcF) interval.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Jul 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ArriVent BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lepu Biopharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066657
- Sponsor's protocol ID
- MRG007-001/ARR-217-101
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07066657
- Acronym / sponsor ID
- MRG007-001/ARR-217-101
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Keywords
- MRG007, Advanced or Metastatic Solid Tumors, CDH17, ARR-217, ADC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- ArriVent BioPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lepu Biopharma Co., Ltd.
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG007 | Experimental | Drug: MRG007 |
| MRG007 and Bevacizumab | Experimental | Drug: MRG007 and Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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; 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.
- ≥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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG007Also: ARR-217MRG007 will be administrated as specified in the protocol. | Drug | MRG007 |
| MRG007 and BevacizumabAlso: ARR-217MRG007 will be administered as specified in the protocol | Drug | MRG007 and Bevacizumab |
Primary outcome
Dose Limiting Toxicity (DLT) - Phase Ia
Time frame: Baseline to Day 21 of the first treatment cycle
Serious Adverse Events (SAEs)
Time frame: 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
Treatment-Emergent Adverse Event (TEAE)
Time frame: 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
Treatment-Related Adverse Event
Time frame: 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.
Objective Response Rate (ORR) as assessed by investigator - Phase Ib
Time frame: 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.
11 secondary outcomes
Objective Response Rate (ORR) - Phase Ia
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 24 months)
Incidence of anti-drug antibody (ADA)
Time frame: Baseline to 30 days after the last dose.
Incidence of neutralizing antibody (NAb)
Time frame: Baseline to 30 days after the last dose.
Tmax
Time frame: Baseline to 30 days after the last dose of study treatment
Cmax
Time frame: Baseline to 30 days after the last dose of study treatment
AUC0-t
Time frame: Baseline to 30 days after the last dose of study treatment
QTc interval
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRG007 and MRG007 and Bevacizumab in people with Locally Advanced or Metastatic Solid Tumors and Colorectal Cancer, run by ArriVent BioPharma, Inc. at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials ((888) 622-2827, ClinicalTrials.gov@ArriVent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) - Phase Ia (time frame: Baseline to Day 21 of the first treatment cycle). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.