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- ||| MIL62 / Beijing Mabworks Biotech
Trial primary completion date: A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - Nov 20, 2024
P3, N=150, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial primary completion date: Dec 2024 --> Mar 2025
- || MIL62 / Beijing Mabworks Biotech
Trial primary completion date: A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - Nov 20, 2024
P1/2, N=120, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial primary completion date: Dec 2024 --> Mar 2025 Trial primary completion date: Nov 2024 --> Mar 2025
- MIL62 / Beijing Mabworks Biotech
Type II Glycoengineered Anti-CD20 Antibody MIL62 or Cyclosporine in Chinese Primary Membranous Nephropathy: A Multicenter, Randomized, Open-Label Phase 1b/2 Trial (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1649;
P3
MIL62 was superior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months. A phase 3 clinical trial of MIL62 in pMN is ongoing (NCT05862233).
- || MIL62 / Beijing Mabworks Biotech
P1/2 data, Journal: Efficacy and safety of MIL62, a novel glycoengineered type ? anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. (Pubmed Central) - Jul 15, 2024
P1b/2, P3
MIL62, a novel glycoengineered type ? anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in
- Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech, finotonlimab (SCT-I10A) / Sinocelltech, Ambezhu (bevacizumab biosimilar) / Sinocelltech
SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial. (Hall A; Poster Bd #: 72) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3823;
P2/3
anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in The combination of SCT-I10A and SCT510 showed substantial clinical advantages and an acceptable safety profile in patients with advanced HCC, thereby supporting its suitability as a first-line treatment option for HCC.
- || MIL93 / Beijing Mabworks Biotech
Trial completion date, Trial primary completion date, Metastases: A Clinical Study of MIL93 in Solid Tumors. (clinicaltrials.gov) - Mar 12, 2024
P1, N=228, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
The combination of SCT-I10A and SCT510 showed substantial clinical advantages and an acceptable safety profile in patients with advanced HCC, thereby supporting its suitability as a first-line treatment option for HCC. Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
- MBS309 / Beijing Mabworks Biotech
Preclinical characterization of MBS309, a conditionally active PD-1-dependent IL-2 mutation with significantly superior anti-tumor efficacy with safety (Section 4) - Mar 5, 2024 - Abstract #AACR2024AACR_6989;
In our in vivo tumor murine models, 1mg/kg MBS309 showed much better suppression effect in MC38/hPD-L1 tumor than 1mg/kg RG6279 analog and Pembrolizumab (1mg/kg) combination with wild type IL-2 (0.1mg/kg); And MBS309 at the dosage of 5mg/kg can significantly inhibit tumor growth in PD-1 resistant Pan-02 xenograft models without any side-effects observed, while RG6279 analog at the dosage of 5mg/kg induced severe body reduction of the mice and resulted in 80% (4/5) mice death after two dosages...20mg/kg of MBS309 was well tolerated in mouse, while 10mg/kg of RG6279 analog or PF-07209960 analog show severe toxicity and resulted in death of all the mice...And it shows much higher anti-tumor effect compared to anti-PD-1/-L1 antibodies alone in both PD-1 sensitive and resistant tumor models. MBS309 has demonstrated a favorable safety profile and highly anti-tumor activities in vivo, which has the potential to supporting its clinical development for the treatment of cancer.
- | MBS301 / Beijing Mabworks Biotech
Trial completion date, Trial primary completion date, Metastases: Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor (clinicaltrials.gov) - Oct 23, 2023
P1, N=34, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
MBS309 has demonstrated a favorable safety profile and highly anti-tumor activities in vivo, which has the potential to supporting its clinical development for the treatment of cancer. Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Dec 2024
- || MIL62 / Beijing Mabworks Biotech
Trial completion date, Trial primary completion date: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) (clinicaltrials.gov) - Oct 23, 2023
P1b/2, N=53, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Dec 2024 Trial completion date: May 2023 --> May 2025 | Trial primary completion date: Jan 2023 --> May 2024
- ||| MIL62 / Beijing Mabworks Biotech
Trial primary completion date: MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma (clinicaltrials.gov) - Aug 14, 2023
P3, N=168, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial completion date: May 2023 --> May 2025 | Trial primary completion date: Jan 2023 --> May 2024 Trial primary completion date: Mar 2023 --> Mar 2024
- || MIL95 / Beijing Mabworks Biotech, Keymed Biosciences
Trial completion date, Trial primary completion date, Metastases: A Clinical Study of MIL95 in Advanced Malignancies. (clinicaltrials.gov) - Aug 14, 2023
P1, N=58, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial primary completion date: Mar 2023 --> Mar 2024 Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: May 2023 --> Dec 2022
- |||| MIL62 / Beijing Mabworks Biotech
Enrollment open: A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - Aug 14, 2023
P3, N=150, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: May 2023 --> Dec 2022 Not yet recruiting --> Recruiting
- |||| MIL62 / Beijing Mabworks Biotech
Enrollment open: A Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 14, 2023
P2/3, N=200, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||| MIL62 / Beijing Mabworks Biotech
New P3 trial: A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - May 17, 2023
P3, N=150, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- MIL62 / Beijing Mabworks Biotech
THE TYPE ? ANTI-CD20 MONOCLONAL ANTIBODY MIL62 OR CYCLOSPORINE IN CHINESE PRIMARY MEMBRANOUS NEPHROPATHY: PRELIMINARY RESULTS OF A PHASE ?B/? TRIAL (Focussed Oral Room 2) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1715;
P1/2
MIL62 had a manageable safety profile. This phase Ib/II preliminary data warrant further phase III clinical trials of MIL62 in pMN.
- MIL95 / Beijing Mabworks Biotech, Keymed Biosciences
A first-in-human study of MIL95, an anti-CD47 monoclonal antibody (mAb), in patients with advanced solid tumors and lymphomas. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4575;
P1
Further antitumor activity may need to be combined with other therapies. Clinical trial information: NCT04651348.
- |||||||| MIL62 / Beijing Mabworks Biotech
New P2/3 trial: A Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - Apr 3, 2023
P2/3, N=200, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- || MIL93 / Beijing Mabworks Biotech
Trial primary completion date, Metastases: A Clinical Study of MIL93 in Solid Tumors. (clinicaltrials.gov) - Mar 17, 2023
P1, N=228, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Clinical trial information: NCT04651348. Trial primary completion date: Feb 2023 --> Aug 2023
- MBS307 / Beijing Mabworks Biotech
Preclinical characterization of MBS307, a CD40/PD-L1 trispecific antibody with increased therapeutic window and efficacy (Section 25; Poster Board #13) - Mar 14, 2023 - Abstract #AACR2023AACR_4020;
Furthermore, unlike single CD40 mAB treatment at 10 mg/kg, MBS307 at high dose 15 mg/kg did not elevate liver enzymes and decrease mouse body weight, indicating its improved safety profile. In summary, our data show MBS307 is a functional base designed tri-specific antibody with promising anti-tumor efficacy and safety profile by simultaneously blocking PD-1 and stimulating CD40 pathways.
- ||||||| Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech
Trial completion, Metastases: mil60 Versus Bevacizumab in Patients With Treatment-na (clinicaltrials.gov) - Jan 31, 2023
P3, N=517, Completed, Sponsor: Beijing Mabworks Biotech Co., Ltd.
In summary, our data show MBS307 is a functional base designed tri-specific antibody with promising anti-tumor efficacy and safety profile by simultaneously blocking PD-1 and stimulating CD40 pathways. Unknown status --> Completed
- MIL93 / Beijing Mabworks Biotech
Safety and preliminary efficacy of MIL93 in patients with advanced solid tumors: The monotherapy part of a phase 1 trial. (Available On Demand; Poster Board No. M13) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_305;
P1
Combination of MIL93 and standard treatment in selected tumor types is currently underway. Clinical trial information: NCT04671875.
- | MBS301 / Beijing Mabworks Biotech
Trial completion date, Trial primary completion date, Metastases: Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor (clinicaltrials.gov) - Nov 14, 2022
P1, N=34, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Clinical trial information: NCT04671875. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
- ||| Yinuokai (orelabrutinib) / InnoCare, Biogen
Enrollment closed, Enrollment change: A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma (clinicaltrials.gov) - Nov 14, 2022
P1/2, N=43, Active, not recruiting, Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Aug 2022 --> Aug 2023 Recruiting --> Active, not recruiting | N=120 --> 43
- MIL62 / Beijing Mabworks Biotech, Yinuokai (orelabrutinib) / InnoCare, Biogen
The Type II Glycoengineered Humanized Anti-CD20 Monoclonal Antibody MIL62 Combined with Orelabrutinib in Chinese Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma: Updated Results of a Multicenter, Phase I/IIa Trial (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_6083;
Background:A novel glycoengineered type II anti-CD20 antibody, MIL62 with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively. MIL62 combined with orelabrutinib showed promising efficacy in previously treated patients with r/r DLBCL, including those with resistance to rituximab, and has a manageable safety profile.
- Yinuokai (orelabrutinib) / InnoCare, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Efficacy and Safety of Lenalidomide, Anti-PD-1 Antibody Combined with Orelabrutinib or Rituximab in the Treatment of Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_2491;
Lenalidomide, anti-PD-1 antibody combined with orelabrutinib or rituximab regimen is effective and well-tolerated for patients with R/R DLBCL in this phase II study. This study provides a potential novel strategy for the treatment of R/R DLBCL.
- || Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech, TQ-B2302 (bevacizumab biosimilar) / Sino Biopharm
Clinical, P1 data, Journal: A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects. (Pubmed Central) - Sep 14, 2022
P1
This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects. This trial was registered in ClinicalTrials.gov (Number: NCT05476341, date registered: 25, Jul 2022) and Drug Clinical Trial Registration and Information Disclosure Platform (Number: CTR20171308, date registered: 16, Nov 2017).
- ||| Tyvyt (sintilimab) / Eli Lilly, Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech, Byvasda (bevacizumab biosimilar) / Innovent Biologics, Etana
P3 data, P3 data: top line, Journal, IO biomarker: Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. (Pubmed Central) - Sep 10, 2022
P3
This trial was registered in ClinicalTrials.gov (Number: NCT05476341, date registered: 25, Jul 2022) and Drug Clinical Trial Registration and Information Disclosure Platform (Number: CTR20171308, date registered: 16, Nov 2017). In this interim analysis, sintilimab plus IBI305 plus cisplatin and pemetrexed was generally efficacious and well tolerated in patients with EGFR-mutated NSCLC who progressed after receiving EGFR tyrosine-kinase inhibitor therapy.
- | Tyvyt (sintilimab) / Eli Lilly, Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech
Journal, PD(L)-1 Biomarker, IO biomarker: Serum concentration of CD137 and tumor infiltration by M1 macrophages predict the response to sintilimab plus bevacizumab biosimilar in advanced hepatocellular carcinoma patients. (Pubmed Central) - Aug 24, 2022
Sintilimab plus IBI305 was well tolerated and was effective therapy for advanced HCC. Both serum concentrations of CD137 and tumor infiltration of M1 macrophages may serve as potential predictive biomarkers.
- || MIL62 / Beijing Mabworks Biotech
Trial primary completion date: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) (clinicaltrials.gov) - Aug 24, 2022
P1b/2, N=53, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Both serum concentrations of CD137 and tumor infiltration of M1 macrophages may serve as potential predictive biomarkers. Trial primary completion date: Jun 2022 --> Jan 2023
- || MIL95 / Beijing Mabworks Biotech, Keymed Biosciences
Trial completion date, Trial primary completion date, Metastases: A Clinical Study of MIL95 in Advanced Malignancies. (clinicaltrials.gov) - Aug 24, 2022
P1, N=58, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial primary completion date: Jun 2022 --> Jan 2023 Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: May 2022 --> May 2023
- |||| MIL62 / Beijing Mabworks Biotech
Enrollment open: A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) - Aug 24, 2022
P3, N=140, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: May 2022 --> May 2023 Not yet recruiting --> Recruiting
- | Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech, Avastin (bevacizumab) / Roche, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Retrospective data, Journal: Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb. (Pubmed Central) - Jul 30, 2022
Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states.
- |||| MIL62 / Beijing Mabworks Biotech
New P1/2 trial: A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - Jun 1, 2022
P1/2, N=120, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- MIL93 / Beijing Mabworks Biotech
Safety, tolerability, pharmacokinetics and preliminary efficacy of MIL93, an anti-Claudin18.2 monoclonal antibody, in patients with advanced solid tumors: A phase 1 clinical study. (Available On Demand; 78) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5123;
P1
Pts with CLDN18.2-positive gastric cancer responded to the treatment. Dose escalation and expansion in selected tumor types is currently underway.
- |||||||| MIL62 / Beijing Mabworks Biotech
New P3 trial: A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) - Apr 5, 2022
P3, N=140, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- | MBS301 / Beijing Mabworks Biotech
Trial completion date, Trial primary completion date, Metastases: Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor (clinicaltrials.gov) - Mar 3, 2022
P1, N=34, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Dose escalation and expansion in selected tumor types is currently underway. Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: May 2020 --> Aug 2022
- |||| MIL62 / Beijing Mabworks Biotech
Enrollment open: MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma (clinicaltrials.gov) - Feb 15, 2022
P3, N=168, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: May 2020 --> Aug 2022 Not yet recruiting --> Recruiting
- ||| MIL93 / Beijing Mabworks Biotech
Enrollment open, Metastases: A Clinical Study of MIL93 in Solid Tumors. (clinicaltrials.gov) - Feb 15, 2022
P1, N=228, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| MIL95 / Beijing Mabworks Biotech, Keymed Biosciences
Enrollment open, Metastases: A Clinical Study of MIL95 in Advanced Malignancies. (clinicaltrials.gov) - Feb 15, 2022
P1, N=58, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| MIL 60 (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech
Clinical, P3 data, Journal: Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study. (Pubmed Central) - Nov 30, 2021
P3
The efficacy, safety and immunogenicity of MIL60 were similar with bevacizumab, providing an alternative treatment option for advanced or recurrent non-squamous NSCLC. This study was sponsored by Betta Pharmaceutical Co., Ltd.
- MIL62 / Beijing Mabworks Biotech
The Type II Glycoengineered Humanized Anti-CD20 Monoclonal Antibody MIL62 Combined with Lenalidomide in Chinese Patients with Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma: Results of a Multicenter, Single-Arm, Phase 1b/2 Trial (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2919;
P1b/2, P3
A multi-center, randomized, open-label, phase III trial of MIL62 plus lenalidomide versus lenalidomide in rituximab refractory FL patients is ongoing (NCT04834024). Keywords: MIL62; type II anti-CD20 monoclonal antibody; recurrent/refractory follicular lymphoma; recurrent/refractory marginal zone lymphoma
- ||| Yinuokai (orelabrutinib) / InnoCare, Biogen
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma (clinicaltrials.gov) - Aug 9, 2021
P1/2, N=120, Recruiting, Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Keywords: MIL62; type II anti-CD20 monoclonal antibody; recurrent/refractory follicular lymphoma; recurrent/refractory marginal zone lymphoma Not yet recruiting --> Recruiting | N=50 --> 120 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Dec 2025
- MIL 60 (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech
[VIRTUAL] Efficacy and safety of MIL60, a bevacizumab biosimilar, in combination with paclitaxel/carboplatin in patients with advanced or recurrent non-squamous non-small cell lung cancer: A randomized, double-blind, multicenter phase III study () - Jul 22, 2021 - Abstract #ESMO2021ESMO_2624;
P3
Not yet recruiting --> Recruiting | N=50 --> 120 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Dec 2025 MIL60 and BEV are equivalent in clinical efficacy in non-squamous non-small cell lung cancer patients, and the safety, Pop PK and immunogenicity of MIL60 was similar with BEV.
- MIL62 / Beijing Mabworks Biotech, orelabrutinib (ICP-022) / Biogen
[VIRTUAL] Preliminary phase I/II study results of orelabrutinib combined with MIL62 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma () - Jul 22, 2021 - Abstract #ESMO2021ESMO_2165;
P1/2
Background: MIL62 is a glycoengineered anti-CD20 antibody with a nearly completely afucosylated N-glycans in Fc region that demonstrated superior activity in comparison with rituximab and obinutuzumab in vitro and in vivo, respectively. Orelabrutinib and MIL62 combination therapy was generally well tolerated without unexpected toxicities and demonstrated encouraging clinical activity in patients with relapsed/refractory B-cell NHL.
- ||| MIL62 / Beijing Mabworks Biotech
Enrollment open: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) (clinicaltrials.gov) - Jun 18, 2021
P1b/2, N=53, Recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Orelabrutinib and MIL62 combination therapy was generally well tolerated without unexpected toxicities and demonstrated encouraging clinical activity in patients with relapsed/refractory B-cell NHL. Not yet recruiting --> Recruiting
- || MIL62 / Beijing Mabworks Biotech
Trial completion: A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas (clinicaltrials.gov) - Jun 16, 2021
P1, N=27, Completed, Sponsor: Beijing Mabworks Biotech Co., Ltd.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||| MIL62 / Beijing Mabworks Biotech
New P3 trial: MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma (clinicaltrials.gov) - Apr 5, 2021
P3, N=168, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- ||| MIL93 / Beijing Mabworks Biotech
New P1 trial, Metastases: A Clinical Study of MIL93 in Solid Tumors. (clinicaltrials.gov) - Dec 16, 2020
P1, N=228, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- ||| MIL95 / Beijing Mabworks Biotech, Keymed Biosciences
New P1 trial, Metastases: A Clinical Study of MIL95 in Advanced Malignancies. (clinicaltrials.gov) - Dec 3, 2020
P1, N=58, Not yet recruiting, Sponsor: Beijing Mabworks Biotech Co., Ltd.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Phase I study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma (On-Demand) - Jul 24, 2020 - Abstract #ESMO2020ESMO_1711;
P1
Ltd. Clinical trial identification: NCT04103905; September 26, 2019.