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Also known as MGC026 Dose Escalation
MGC026 · 1 trial · 22 indications
| Arm | Type | Description |
|---|---|---|
| Module A Cohort 1 | EXPERIMENTAL | MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks. |
| Module A Cohort 2 | EXPERIMENTAL | - |
| Module A Cohort 3 | EXPERIMENTAL | - |
| Module A Cohort 4 | EXPERIMENTAL | - |
| Module A Cohort 5 | EXPERIMENTAL | - |
| Module A Cohort 6 | EXPERIMENTAL | - |
| Module A Expansion cohort 1 | EXPERIMENTAL | - |
| Module A Expansion cohort 2 | EXPERIMENTAL | - |
| Module A Expansion cohort 3 | EXPERIMENTAL | - |
| Module A Expansion cohort 4 | EXPERIMENTAL | - |
| Module A Expansion Cohort 5 | EXPERIMENTAL | - |
| Module A Expansion Cohort 6 | EXPERIMENTAL | - |
| Module A Expansion Cohort 7 | EXPERIMENTAL | - |
| Module A Expansion Cohort 8 | EXPERIMENTAL | - |
| Module B Part 1, Dose Level 1 | EXPERIMENTAL | - |
| Module B Part 1, Dose Level 2 | EXPERIMENTAL | Module B Part 2, Dose Expansion |
| Name | Type | Description |
|---|---|---|
| MGC026 Dose Escalation | BIOLOGICAL | Escalating doses of MGC026 |
| MGC026 Dose for Expansion | BIOLOGICAL | MGC026 recommended dose for expansion |
| Pembrollizumab | BIOLOGICAL | 200 mg, IV, every 3 weeks. |
| vobramitamab tavatecan | BIOLOGICAL | less than RDE dose level, IV, every 3 weeks |
Inclusion Criteria: * Adults ≥ 18 years old, able to provide informed consent * Adequate performance and laboratory parameters * Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an arc...
| 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 |
MGC026 is being studied for the treatment of advanced solid tumors. The Phase 1 trial enrolls adults with a range of advanced or metastatic cancers, including non-small cell lung cancer, small-cell lung cancer, head and neck squamous cell carcinoma, bladder cancer, melanoma, colorectal cancer, gastric cancer, pancreatic cancer, and several other tumor types.
MGC026 targets B7-H3, a molecule expressed across a range of solid tumors. MGC026 is a monoclonal antibody designed to bind B7-H3. Targeting B7-H3 is the mechanism under evaluation in the Phase 1 study in advanced solid tumors.
MGC026 is being developed by MacroGenics, Inc., which trades on Nasdaq under the ticker MGNX. MacroGenics is the sponsor of the Phase 1 study of MGC026 in advanced solid tumors.
MGC026 is in Phase 1 clinical development. It is investigational and is being evaluated in a single recruiting Phase 1 dose escalation and expansion study in participants with advanced solid tumors. No Phase 2 or later-stage trial of MGC026 is listed.
MGC026 is being studied in NCT06242470, titled A Study of MGC026 in Participants With Advanced Solid Tumors. The trial is a recruiting Phase 1 study with planned enrollment of 394 participants aged 18 years and older, open to all sexes, and conducted in the United States, Australia, and the United Kingdom.
Yes. MGC026 Dose Escalation is another name used for MGC026, referring to the dose escalation portion of its Phase 1 study in advanced solid tumors. Searches for either name refer to the same MacroGenics B7-H3 monoclonal antibody program.