An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.
Overview
- Phase
- Phase 2
- Intervention
- MRG003
- Conditions
- Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
- Sponsor
- Shanghai Miracogen Inc.
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR) by Investigator per RECIST v1.1
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.
Detailed Description
The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing to sign the ICF and follow the requirements specified in the protocol.
- •Expected survival time≥3 months.
- •Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.
- •Failed prior platinum and/or anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •ECOG performance score 0 or
- •Organ functions and coagulation function must meet the basic requirements.
- •Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.
- •Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion Criteria
- •History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.
- •≥Grade 2 peripheral neuropathy
- •Prior anti-tumor therapy with MMAE/MMAF ADCs
- •Expected surgery or any other form of systemic or local anti-tumor therapy.
- •History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery.
- •Known active CNS metastasis and/or cancerous meningitis.
- •Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE.
- •Uncontrolled or poorly controlled heart disease.
- •History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.
- •Known history of malignancy.
Arms & Interventions
Experimental Arm
MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study.
Intervention: MRG003
Experimental Arm
MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study.
Intervention: MRG003+HX008
Outcomes
Primary Outcomes
Objective Response Rate (ORR) by Investigator per RECIST v1.1
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.
Secondary Outcomes
- Overall Survival (OS)(Baseline to study completion (up to 24 months))
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose of study treatment)
- Duration of Response (DoR)(Baseline to study completion (up to 24 months))
- Progression Free Survival (PFS) as assessed by investigator(Baseline to study completion (up to 24 months))
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
- AUClast(Baseline to 30 days after the last dose of study treatment)
- Serious Adverse Events (SAEs)(Baseline to 45 days after the last dose of study treatment)
- Tmax(Baseline to 30 days after the last dose of study treatment)
- Cmax(Baseline to 30 days after the last dose of study treatment)