13 completed, 1 active not recruiting, 1 recruiting. 9 Phase 1, 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 9 |
| Phase 3 | 6 | Completed 4, Active not recruiting 1, Recruiting 1 |
Follow mAbxience Research S.L.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, US- sourced Opdivo® - Advanced (Unresectable or Metastatic) Melanoma | Phase 3 | Recruiting | mAbxience Research S.L. | 632 | 2025-12-29 | 2026-01-21 |
| A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda®, US-sourced Keytruda® - Non Squamous Non Small Cell Lung Cancer | Phase 3 | Active not recruiting | mAbxience Research S.L. | 726 | 2024-12-30 | 2026-09-10 |
| A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [Proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis MB04 (proposed biosimilar to etanercept), Enbrel (etanercept) - Rheumatoid Arthritis (RA) | Phase 3 | Completed | mAbxience Research S.L. | 501 | 2024-10-03 | 2026-10-08 |
| A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders MB04, US License Enbrel, EU Source Enbrel - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 141 | 2024-03-07 | 2025-09-30 |
| A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers. MB05 (Proposed palivizumab biosimilar), EU-Synagis®, US-Synagis® - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 150 | 2022-06-15 | 2025-04-02 |
| A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis. MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium - Postmenopausal Women With Osteoporosis | Phase 3 | Completed | mAbxience Research S.L. | 558 | 2022-03-16 | 2025-03-21 |
| A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva MB09, US-sourced Xgeva, EU-sourced Xgeva - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 257 | 2022-03-01 | 2025-01-03 |
| A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®. MB02-SP, MB02-DM, US licenced Avastin® - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 114 | 2021-01-11 | 2024-09-19 |
| Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV Palivizumab, Placebo, RSV-A Memphis 37b virus - Healthy Adult Participants | Phase 1 | Completed | mAbxience Research S.L. | 56 | 2020-07-06 | 2021-10-04 |
| Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers MB02 (Bevacizumab Biosimilar), EU approved Avastin®, US licenced Avastin® - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 115 | 2019-09-24 | 2023-10-25 |
| A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers MB02 (Bevacizumab Biosimilar), EU approved Avastin® - Healthy Volunteers, Male | Phase 1 | Completed | mAbxience Research S.L. | 49 | 2019-08-02 | 2021-03-23 |
| A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin - Non-small Cell Lung Cancer | Phase 3 | Completed | mAbxience Research S.L. | 627 | 2018-02-06 | 2021-04-26 |
| A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers MB02, US licenced Avastin®, EU approved Avastin® - Healthy Volunteers | Phase 1 | Completed | mAbxience Research S.L. | 114 | 2017-12-07 | 2021-03-23 |
| Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients Bevacizumab biosimilar (BEVZ92), Avastin® (bevacizumab, reference product) - Metastatic Colorectal Cancer (mCRC) | Phase 1 | Completed | mAbxience Research S.L. | 142 | 2014-10-29 | 2019-07-23 |
| Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma RTXM83, Mabthera - Diffuse Large B-cell Lymphoma | Phase 3 | Completed | mAbxience Research S.L. | 272 | 2013-05-01 | 2019-09-26 |
Neoplasm Metastasis (2) · Arthritis, Rheumatoid (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Lymphoma, Large B-Cell, Diffuse (1) · Lymphoma, Non-Hodgkin (1) · Melanoma (1)
Bevacizumab (4) · Carboplatin (2) · Etanercept (2) · BEVZ92 (1) · Calcium (1) · Cisplatin (1) · Fluorouracil (1) · Irinotecan (1) · Oxaliplatin (1) · Paclitaxel (1) · Palivizumab (1) · Pemetrexed (1) · QL1206 (1) · Rituximab (1) · Vitamin D (1)
Brazil (4) · Georgia (4) · Poland (4) · Serbia (4) · Bulgaria (3) · India (3) · Malaysia (3) · Mexico (3) · Philippines (3) · Spain (3) · Ukraine (3) · Argentina (2) · Greece (2) · Hungary (2) · Japan (2)
Alexandra Cole, MD (1) · Angela Sinn, MD (1) · Christian Schwabe, MD (1) · Monika Tomaszewska-Kiecana, MD (1) · Muna Albayaty, MBChB,FFPM,MSc (1) · Sungeen Hill, MD (1) · Sunu Valasseri, MBBS, MSc (1)
PMID 30262136, PMID 33914256, PMID 34269848, PMID 34374114, PMID 41900779