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Also known as vobramitamab duocarmazine
MGC018 · 2 trials · 8 indications
Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to\<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| MCG018 | EXPERIMENTAL | - |
| Cohort -1 | EXPERIMENTAL | vobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks |
| Cohort 1 | EXPERIMENTAL | vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks |
| Cohort 2 | EXPERIMENTAL | vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks |
| Cohort 3 | EXPERIMENTAL | vobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks |
| Cohort 4 | EXPERIMENTAL | vobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks |
| Cohort 5 | EXPERIMENTAL | vobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks |
| Cohort Expansion | EXPERIMENTAL | maximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks |
| Name | Type | Description |
|---|---|---|
| MGC018 | DRUG | Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle |
| vobramitamab duocarmazine | BIOLOGICAL | Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3. |
| lorigerlimab | BIOLOGICAL | Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4. |
Inclusion Criteria: 1. Age greater than or equal to 18 years at time of signing Informed consent form (ICF) 2. Ability to comply with the study protocol, in the investigator's judgment. 3. Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive t...
MGC018 is being studied for the treatment of relapsed or refractory extensive-stage small-cell lung cancer. It is an investigational antibody-drug conjugate being developed by MacroGenics, Inc. for this oncology indication. It is not yet approved for commercial use and remains in clinical development.
MGC018 targets B7-H3, a cell-surface antigen. It is an antibody-drug conjugate designed to bind B7-H3 and deliver a cytotoxic payload to cells expressing that antigen. B7-H3 is the molecular target of the agent, and the trial in small-cell lung cancer uses biomarker selection.
MGC018 is being developed by MacroGenics, Inc., which trades on the Nasdaq under the ticker MGNX. MacroGenics is the sponsor of the clinical program evaluating the antibody-drug conjugate in extensive-stage small-cell lung cancer.
MGC018 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The ongoing study is a Phase 2 trial in patients with relapsed or refractory extensive-stage small-cell lung cancer.
MGC018 is being evaluated in the Phase 2 trial NCT06227546, titled MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer. The study is active but not recruiting, is uncontrolled, is not randomized, and has enrolled 9 participants in the United States.
The NCT06227546 trial enrolls adults aged 18 years and older of all sexes with relapsed or refractory extensive-stage small-cell lung cancer. It does not accept healthy volunteers, and participants are selected based on a biomarker. The study is being conducted in the United States.