Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MGC018
vobramitamab duocarmazine · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Vobramitamab duocarmazine is an investigational antibody-drug conjugate being developed by MacroGenics, Inc. for advanced solid tumors. It is in Phase 1 clinical development and has been studied in a completed trial that enrolled 31 participants with advanced solid tumors, including castration-resistant prostate cancer, melanoma, pancreatic ductal carcinoma, hepatocellular cancer, epithelial ovarian cancer, and renal cell carcinoma.
Vobramitamab duocarmazine is being studied for the treatment of advanced solid tumors. The completed Phase 1 trial enrolled participants with advanced solid tumors including castration-resistant prostatic cancer, malignant melanoma, pancreatic ductal carcinoma, hepatocellular cancer, epithelial ovarian cancer, and renal cell carcinoma. It is investigational and has not been approved for any indication.
Vobramitamab duocarmazine is developed by MacroGenics, Inc., which trades on the Nasdaq under the ticker MGNX. MacroGenics is the sponsor of the clinical program evaluating the drug in advanced solid tumors.
Vobramitamab duocarmazine is in Phase 1 clinical development. Its single trial, NCT05293496, is a completed Phase 1 study. The drug is investigational and has not been approved by the FDA for any indication.
Vobramitamab duocarmazine has been evaluated in one clinical trial, NCT05293496, titled A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors. This Phase 1 trial was completed and enrolled 31 participants across sites in the United States. It was a controlled study without randomization or double-blinding.
Yes, vobramitamab duocarmazine is also known as MGC018. The Phase 1 trial NCT05293496 lists the study drug as MGC018, which is the alternate designation for vobramitamab duocarmazine, an antibody-drug conjugate developed by MacroGenics for advanced solid tumors.