A Study of MRG003 in the Treatment of Patients With EGFR-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: NCT05688605|
Recruitment Status : Recruiting
First Posted : January 18, 2023
Last Update Posted : January 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: MRG003+HX008||Phase 1 Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||18 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 Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors|
|Actual Study Start Date :||June 30, 2022|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||July 2025|
MRG003 will be administrated via intravenous infusion at 1.5, 2.0 mg/kg (MTD=2.5 mg/kg) once on Day 1 of every 3 weeks (21-day cycle).
HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day cycle).
- Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days after the first dose of the last patient of the MTD group ]MTD is the highest dose with the proportion of DLT less than 1/3
- Recommended Phase II Dose (RP2D) [ Time Frame: Baseline to study completion (up to 12 months) ]The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
- Objective Response Rate (ORR) [ Time Frame: Baseline to study completion (up to 12 months) ]ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
- Duration of Response (DOR) [ Time Frame: Baseline to study completion (up to 12 months) ]DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
- Disease Control Rate (DCR) [ Time Frame: Baseline to study completion (up to 12 months) ]DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.
- Progression Free Survival (PFS) [ Time Frame: Baseline to study completion (up to 12 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) [ Time Frame: Baseline to study completion (up to 12 months) ]OS is defined as the duration from the start of treatment to death of any cause.
- Immunogenicity (ADA) [ Time Frame: Baseline to 90 days after the last dose. ]The proportion of patients with positive ADA results.
- Adverse Events (AEs) [ 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 whether or not the event is considered related to the study drug.
- Serious Adverse Events (SAEs) [ Time Frame: Baseline to 90 days after the last dose of study treatment ]Adverse events that are difficult to deal with in clinical drug research
- PK parameters: concentration-time curve [ Time Frame: Baseline to 90 days after the last dose. ]Plot of drug concentration changing with time after drug administration
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): NCT05688605
|Contact: Program Directorfirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ruihua Xu, M.D. 86-18127912775 email@example.com|
|Hunan Cancer Hospital||Not yet recruiting|
|Changsha, Hunan, China, 410029|
|Contact: Yingrui Shi, M.D. 13607441956 firstname.lastname@example.org|
|Principal Investigator:||Ruihua Xu, M.D.||Sun Yat-sen University|