Table 1.
Published and Ongoing Clinical Trials with Margetuximab (Clinicaltrials.gov as of December 8, 2021)
| Study Name (NCT Identifier) | Phase | Sample Size | Design | Objectives | Status |
|---|---|---|---|---|---|
| Breast cancer | |||||
| Margetuximab or trastuzumab (MARGOT- NCT04425018) | Phase 2 | 171 | Randomized study comparing neoadjuvant paclitaxel and pertuzumab in combination with margetuximab or trastuzumab for stage II–III HER2+ breast cancer | pCR, residual cancer burden, radiologic response rate, adverse events, EFS, RFI, OS | Recruiting |
| Study to evaluate pharmacokinetics of margetuximab in Chinese patients with HER2+ metastatic breast cancer (NCT04398108) | Phase 1 | 16 | Single-arm study of margetuximab in combination of capecitabine, vinorelbine, gemcitabine in metastatic HER2+ breast cancer | Pharmacokinetic studies (maximal concentration, time of maximal concentration, area under the curve and half-life) | Completed |
| Study to evaluate efficacy and safety of margetuximab in Chinese patients with HER2+ metastatic breast cancer (NCT04262804) | Phase 2 | 120 | Randomized trial comparing trastuzumab plus chemotherapy (capecitabine, vinorelbine, gemcitabine) vs margetuximab plus chemotherapy in metastatic HER2+ breast cancer | PFS, OS, ORR, DoR, CBR, allelic variation of Fc-receptor | Recruiting |
| Margetuximab in relapsed or refractory advanced breast cancer (NCT01828021) | Phase 2 | 25 | Single arm assessing margetuximab as monotherapy in advanced HER2+ breast cancer | Best overall response, response rate | Completed |
| Margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in the treatment of HER2+ metastatic breast cancer (SOPHIA - NCT02492711) | Phase 3 | 624 | Randomized trial comparing trastuzumab plus chemotherapy (capecitabine, vinorelbine, gemcitabine, eribulin) vs margetuximab plus chemotherapy in metastatic HER2+ breast cancer | PFS, OS, incidence of infusion reactions | Active, not recruiting |
| Other malignancies | |||||
| Margetuximab in HER2+ carcinomas (NCT01148849) | Phase 1 | 66 | Single arm assessing margetuximab as monotherapy in HER2+ breast and gastric cancer | Adverse events, maximum tolerated dose | Active, not recruiting |
| MGD013 in patients with unresectable metastatic neoplasms (NCT03219268) | Phase 1 | 353 | Dose escalation and cohort expansion study assessing MGD013 (PD-L1 and LAG3 DART molecule) in advanced solid tumors. Will include a cohort of 99 patients with HER2+ tumors (including breast and gastric) |
Adverse events, maximum tolerated dose, pharmacokinetic studies, percentage of patients with anti-drug antibody, OS | Active, not recruiting |
| Margetuximab and pembrolizumab for advances HER2+ gastric or GEJ cancer (NCT02689284) | Phase 1/2 | 95 | Single-arm study with margetuximab and pembrolizumab | Maximal tolerated dose of margetuximab when given with pembrolizumab, investigate anti-tumor activity per RECIST and ORR | Completed |
| Margetuximab in combination with INCMGA00012 and chemotherapy or MGD013 and chemotherapy in metastatic HER2+ Gastric or GEJ Cancer (MAHOGANY— NCT04082364) | Phase 2/3 | 860 | Randomized study with 5 arms: (1) margetuximab plus INCMGA00012 (anti-PD-L1) (2) margetuximab, INCMGA00012 plus standard chemotherapya (3) margetuximab plus MGD013 (PD-L1 and LAG3 DART molecule) (4) margetuximab, MGD013 plus standard chemotherapy (5) Trastuzumab plus standard chemotherapy |
Adverse events, ORR, OS, PFS, DoR, DCR, patient reported quality of life | Recruiting |
Note: aXELOX and mFOLFOX.
Abbreviations: HER2, human epidermal growth factor receptor 2; PCR, pathologic complete response; EFS, event free survival; RFI, recurrence-free interval; PFS, progression-free survival; OS, overall survival, ORR, objective response rate; DoR, duration of response; CBR, clinical benefit rate; GEJ, gastroesophageal junction; RECIST, response evaluation criteria in solid tumors; PD-L1, program cell death ligand 1.