Locally Advanced or Metastatic Solid TumorsColorectal CancerGastric CancerPancreatic Cancer
Investigational drug(s) / intervention(s)
MRG007MRG007 and Bevacizumab
MRG007: MRG007 will be administrated as specified in the protocol.
MRG007 and Bevacizumab: MRG007 will be administered as specified in the protocol
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) - Phase Ia — Baseline to Day 21 of the first treatment cycle
Serious Adverse Events (SAEs) — 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) — 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 — 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 — 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.
Trial sites (21)
Facility
City
Region
Status
ULCA
Los Angeles
California
Recruiting
UCSF
San Francisco
California
Recruiting
University of Colorado
Aurora
Colorado
Recruiting
Sarah Cannon Research Institute
Denver
Colorado
Recruiting
Sarah Cannon Research Institute
Sarasota
Florida
Recruiting
Sarah Cannon Research Institute
Nashville
Tennessee
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
NEXT Dallas
Irving
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
Fred Hutchinson Cancer Center
Seattle
Washington
Recruiting
Peking University Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Beijing Gobroad Hospital
Beijing
Beijing Municipality
Recruiting
Chongqing Daping Hospital
Chongqing
Chongqing Municipality
Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang
Hangzhou
Recruiting
Harbin Medical University Cancer Hospital
Heilongjiang
Harbin
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
Cancer Hospital of Shandong First Medical University
Shandong
Jinan
Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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