A Study of MRG007 in Patients With Advanced Solid Tumors

Not Applicable

Not yet recruiting

• Conditions: Locally Advanced or Metastatic Solid Tumors
• Interventions: Drug: MRG007

• Registration Number: NCT07066657
• Lead Sponsor: Shanghai Miracogen Inc.

Brief Summary

This is an open-label, multi-center, phase I/II study to evaluate the safety, efficacy, and pharmacokinetics of MRG007 in patients with unresectable locally advanced and metastatic solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2029-05
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• 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 Cadherin17 (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 Eastern Cooperative Oncology Group (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, anti-tumor therapy, radiotherapy, surgery for major organs, or systemic corticosteroid treatment within 4 weeks prior to the first dose of study treatment; received strong CYP3A4 inducers or inhibitors, or small molecular targeting therapy within 2 weeks prior to the first treatment or 5 half-lives of such therapy, whichever is longer.
• 3. ≥Grade 1 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
• 4. Central nervous system and/or meninges metastasis.
• 5. History of severe cardiovascular diseases
• 6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis occurred within 3 months prior to the first treatment.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MRG007	MRG007	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT) - Phase I	Baseline to the end of the first treatment cycle (each cycle is 21 days)
Adverse Events (AEs) - Phase I	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 whether or not the event is considered related to the study drug.
Serious Adverse Events (SAEs) - Phase I	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
Maximum Tolerated Dose (MTD) - Phase I	Baseline to the end of the first treatment cycle (each cycle is 21 days)	The highest dose confirmed wherein less than 2 out of 6, or \< 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT).
Recommended Phase II Dose (RP2D) - Phase I	Baseline to study completion (up to 24 months)	The dose level of MRG007 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Phase I of this study
Objective Response Rate (ORR) as assessed by investigator - Phase II	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 Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) - Phase I	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.
Disease Control Rate (DCR)	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.
Duration of Response (DOR)	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.
Progression Free Survival (PFS) as assessed by investigator	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.
Overall Survival (OS)	Baseline to study completion (up to 24 months)	OS is defined as the duration from the start of treatment to death of any cause.
Adverse Events (AEs) - Phase II	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 whether or not the event is considered related to the study drug.
Serious Adverse Events (SAEs) - Phase II	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
Incidence of anti-drug antibody (ADA)	Baseline to 30 days after the last dose.	The proportion of patients with positive ADA results.
Incidence of neutralizing antibody (NAb)	Baseline to 30 days after the last dose.	The proportion of patients with positive NAb results.
Tmax	Baseline to 30 days after the last dose of study treatment	Time to reach the maximum blood concentration
Cmax	Baseline to 30 days after the last dose of study treatment	Maximum observed blood concentration
AUC0-t	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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China