A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04843709|
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : July 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumors||Drug: MRG004A||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||181 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors|
|Actual Study Start Date :||July 26, 2021|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||June 2025|
All patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).
- Maximum Tolerated Dose (MTD) [ Time Frame: DLT will be evaluated during the first treatment cycle (Day 1-21) ]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) [ Time Frame: Baseline to study completion (up to 24 months) ]The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this study.
- Objective Response Rate (ORR) [ Time Frame: Baseline to study completion (up to 24 months) ]The proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the Independent Central Review (ICR).
- Adverse Events (AEs) [ Time Frame: From signing informed consent until 45 days after the last dose of MRG004A ]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.
- Duration of Response (DoR) [ Time Frame: 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.
- Disease Control Rate (DCR) [ Time Frame: Baseline to study completion (up to 24 months) ]The proportion of patients who achieve CR, PR, or stable disease (SD) ≥ 6 weeks based on RECIST v1.1.
- Progression Free Survival (PFS) [ Time Frame: Baseline to study completion (up to 24 months) ]The time from the date of first study dose to disease progression or death whichever occurs first.
- Overall Survive (OS) [ Time Frame: Baseline to study completion (up to 24 months) ]The time from start of study treatment to date of death as a result of any cause.
- Pharmacokinetics (PK) Parameter of MRG004A: Cmax [ Time Frame: Baseline to 30 days after the last dose of study treatment ]Maximum observed plasma concentration.
- Pharmacokinetics (PK) Parameter of MRG004A: Tmax [ Time Frame: Baseline to 30 days after the last dose of study treatment ]Time to reach the maximum plasma concentration.
- Pharmacokinetics (PK) Parameter of MRG004A: AUClast [ Time Frame: Baseline to 30 days after the last dose of study treatment ]Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration.
- Incidence of anti-drug antibody (ADA) [ Time Frame: Baseline to 30 days after the last dose of study treatment ]The proportion of patients with positive ADA immunogenicity results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843709
|Contact: Jenny Lifirstname.lastname@example.org|
|Contact: Leanne Drummond, Bacheloremail@example.com|
|United States, California|
|Chao Family Comprehensive Cancer Center||Recruiting|
|Orange, California, United States, 92868-3201|
|Contact: Carmen Lu firstname.lastname@example.org|
|United States, New York|
|Memorial Sloan Kettering 60th Street Outpatient Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Amin Yaqubie email@example.com|
|United States, Ohio|
|Gabrail Cancer Center Research||Recruiting|
|Canton, Ohio, United States, 44718|
|Contact: Nashat Y Gabrail, MD 330-492-3345 firstname.lastname@example.org|
|Contact: Carrie Smith 330-492-3345 ext 208 email@example.com|
|The Christ Hospital Cancer Center||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Abby Reed firstname.lastname@example.org|
|United States, Pennsylvania|
|Gettysburg Cancer Center||Recruiting|
|Gettysburg, Pennsylvania, United States, 17325|
|Contact: Christine Nocera email@example.com|
|United States, Virginia|
|Virginia Cancer Specialists||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Contact: Marcy Sullivan, RN, BSN, OCN 703-208-9268 Marcy.Sullivan@usoncology.com|
|Fudan University Shanghai Cancer Center||Not yet recruiting|
|Shanghai, Shanghai, China, 201321|
|Contact: Jian Zhang, M.D 86-18017312991 Syner2000@163.com|
|Contact: Xiaohua Wu, M.D 86-21-64175590 ext 81006 firstname.lastname@example.org|
|Principal Investigator:||Nashat Y Gabrail, MD||Gabrail Cancer Center Research|