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- | Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: A phase II clinical study on the efficacy of disitamab vedotin in advanced HER2-positive Paget (EUDRACT) - Sep 20, 2024
P2, N=36, Not yet recruiting, Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
- | Tai'ai (telitacicept) / Rongchang Pharma
New P1 trial: A comparative pharmacokinetic study of single subcutaneous injection of Telitacicept injection and Telitacicept for injection in healthy Chinese subjects (EUDRACT) - Sep 20, 2024
P1, N=248, Not yet recruiting, Sponsor: West China Hospital of Sichuan University; Remegen biopharmaceutical (Yantai) Co. , Ltd.
- |||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2) (clinicaltrials.gov) - Sep 19, 2024
P3, N=350, Recruiting, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
A prospective, single-arm clinical study of disitamab vedotin (DV) combined with toripalimab for kidney sparing in solitary kidney or renal insufficiency or bilateral multiple upper urinary tract urothelial carcinoma (UTUC) (Exhibition area) - Sep 17, 2024 - Abstract #ESMOAsia2024ESMO_Asia_670;
P2
The primary endpoint is kidney-intact disease-free survival at 1 year (1-yr KIDFS) and the secondary endpoints including time to renal resection, disease-specific survival, overall survival, complete response rate at 6 month and safety. This trial is still open for recruiting and 3 patients have been enrolled.
- Aidixi (disitamab vedotin) / Pfizer
RC48-ADC alone or in combination with immunotherapy for locally advanced or metastatic urothelial carcinoma with HER2 low/null expression: A multicenter, real-world, retrospective study (Exhibition area) - Sep 17, 2024 - Abstract #ESMOAsia2024ESMO_Asia_623;
Notreatment-related death occurred. Conclusions RC48-ADC shows favorable efficacy and manageable safety in metastaticUC patients with HER2 low/null expression in real-world settings, supporting its use.
- Aidixi (disitamab vedotin) / Pfizer
Efficacy and safety of disitamab vedotin in treatment of HER2 expressed advanced or recurrent gynecological cancers (Hall 407) - Sep 17, 2024 - Abstract #ESMOAsia2024ESMO_Asia_249;
The most common adverse events were decreased white blood cell count (36.4%) and decreased neutrophil count (36.4%), with rare occurrence of grade 4 or higher adverse events. Conclusions This study indicates that RC48 has promising efficacy and manageable safety for advanced or recurrent gynecological tumors expressing HER2.
- || Tai'ai (telitacicept) / Rongchang Pharma
Review, Journal: Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. (Pubmed Central) - Sep 9, 2024
This review consolidates information on the mechanistic actions, dosing regimens, pharmacokinetics, efficacy, and safety profile of telitacicept-a dual-targeted biological agent. It integrates findings from prior experiments and pharmacokinetic analyses in the treatment of RA and SLE, striving to offer a comprehensive overview of telitacicept's research advancements.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Aidixi (disitamab vedotin) / Pfizer
Optimizing treatment strategies for HER2-positive breast and gastric cancer: preclinical evaluation of disitamab vedotin, trastuzumab emtansine, trastuzumab deruxtecan, and their combinations therapies in mouse models (Exhibition Hall) - Sep 7, 2024 - Abstract #EORTCNCIAACR2024EORTC_NCI_AACR_304;
Unless they are part of the media programme, embargoed or not consented, all abstracts will be released on 9 October 2024. All other abstracts will be released on the day of presentation.
- | Tai'ai (telitacicept) / Rongchang Pharma
Observational data, Retrospective data, Journal, Real-world evidence, Real-world: Response to telitacicept in systemic lupus erythematosus patients: a real-world, single-center observational study in China. (Pubmed Central) - Aug 31, 2024
All other abstracts will be released on the day of presentation. No abstract available
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Monotherapy: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - Aug 28, 2024
P2, N=88, Recruiting, Sponsor: RemeGen Co., Ltd.
No abstract available Not yet recruiting --> Recruiting
- | Herceptin (trastuzumab) / Roche, Aidixi (disitamab vedotin) / Pfizer
New P1/2 trial: Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens (clinicaltrials.gov) - Aug 26, 2024
P1/2, N=35, Recruiting, Sponsor: Zhejiang Cancer Hospital
- | Aidixi (disitamab vedotin) / Pfizer
Enrollment change, Trial withdrawal, Monotherapy, Metastases: Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Aug 22, 2024
P2, N=0, Withdrawn, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting N=80 --> 0 | Not yet recruiting --> Withdrawn
- | Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease. (clinicaltrials.gov) - Aug 20, 2024
P2, N=36, Not yet recruiting, Sponsor: Fudan University
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open, Trial completion date, Trial primary completion date: A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) (clinicaltrials.gov) - Aug 19, 2024
P3, N=180, Recruiting, Sponsor: RemeGen Co., Ltd.
N=80 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Oct 2027 | Trial primary completion date: Apr 2026 --> Jul 2026
- | Tevimbra (tislelizumab-jsgr) / BeiGene, Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression (clinicaltrials.gov) - Aug 19, 2024
P2, N=40, Recruiting, Sponsor: Tianjin Medical University Cancer Institute and Hospital
- ||| Aidixi (disitamab vedotin) / Pfizer
New trial, Metastases: Neoadjuvant Therapy in Cervical Cancer (clinicaltrials.gov) - Aug 18, 2024
P=N/A, N=48, Not yet recruiting, Sponsor: Kun Song
- ||| Tai'ai (telitacicept) / Rongchang Pharma
New P1 trial: A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects (clinicaltrials.gov) - Aug 12, 2024
P1, N=248, Recruiting, Sponsor: RemeGen Co., Ltd.
- | Tai'ai (telitacicept) / Rongchang Pharma
New P4 trial: The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis (clinicaltrials.gov) - Aug 9, 2024
P4, N=20, Recruiting, Sponsor: Peking University Third Hospital
- | Avastin (bevacizumab) / Roche, Aidixi (disitamab vedotin) / Pfizer, Kaitanni (cadonilimab) / Akesobio
New P2 trial, Combination therapy, IO biomarker: Disitamab Vedotin (RC48) in Combination With AK104 (PD-1/CTLA-4 Bispecific) and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer: a Single-arm, Phase II, Multicenter Study (DAB OCC Study) (clinicaltrials.gov) - Aug 5, 2024
P2, N=39, Not yet recruiting, Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- | Journal, Metastases: Optimal Sequential Strategies for Antibody-Drug Conjugate in Metastatic Breast Cancer: Evaluating Efficacy and Cross-Resistance. (Pubmed Central) - Aug 5, 2024
T-Dxd followed by RC48 may be a potentially beneficial strategy in HER2-positive disease. Further research is needed to elucidate the mechanism of cross-resistance.
- | Tai'ai (telitacicept) / Rongchang Pharma
Journal: Efficacy and safety of telitacicept in patients with lupus nephritis. (Pubmed Central) - Aug 2, 2024
Furthermore, it reduced the dose of glucocorticoid and immunosuppressive medicines. Therefore, telitacicept may be a promising treatment option for individuals with lupus nephritis.
- | Tai'ai (telitacicept) / Rongchang Pharma
Journal: Good efficacy achieved by telitacicept in treatment of systemic lupus erythematosus with alopecia areata. (Pubmed Central) - Jul 26, 2024
Therefore, telitacicept may be a promising treatment option for individuals with lupus nephritis. No abstract available
- Tevimbra (tislelizumab-jsgr) / BeiGene, Avastin (bevacizumab) / Roche, Aidixi (disitamab vedotin) / Pfizer
RESOLUTION: Phase II Study of Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in Patients with HER2 Alteration Advanced NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1571;
Disease response will be assessed by investigator according to RECIST 1.1. Patients enrollment is ongoing.
- Aidixi (disitamab vedotin) / Pfizer
Phase 2 Study of Disitamab Vedotin in Patients with HER2-Expressing Non-Small Cell Lung Cancer (DV-005; Trial in Progress) (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1568;
P2
Secondary endpoints include safety and tolerability, disease control rate, duration of response, progression-free survival, overall survival, incidence of antidrug antibodies, and pharmacokinetic parameters. Enrollment is ongoing in the US and Canada.
- Aidixi (disitamab vedotin) / Pfizer
Phase 2 Study of Disitamab Vedotin in Patients with HER2-Expressing Non-Small Cell Lung Cancer (DV-005; Trial in Progress) (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1558;
P2
Secondary endpoints include safety and tolerability, disease control rate, duration of response, progression-free survival, overall survival, incidence of antidrug antibodies, and pharmacokinetic parameters. Enrollment is ongoing in the US and Canada.
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Combination therapy, Metastases: KEYNOTE-D78: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (clinicaltrials.gov) - Jul 23, 2024
P2, N=332, Recruiting, Sponsor: Seagen Inc.
Enrollment is ongoing in the US and Canada. Trial completion date: Mar 2026 --> May 2028 | Trial primary completion date: Oct 2024 --> Nov 2026
- || RC28-E / Rongchang Pharma
P1 data, Journal: Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial. (Pubmed Central) - Jul 20, 2024
Trial completion date: Mar 2026 --> May 2028 | Trial primary completion date: Oct 2024 --> Nov 2026 RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.
- | Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis (clinicaltrials.gov) - Jul 19, 2024
P2, N=10, Recruiting, Sponsor: Beijing Tongren Hospital
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
A randomized phase 2 study of Disitamab Vedotin (DV) plus toripalimab and chemotherapy versus DV plus toripalimab versus chemotherapy as perioperative treatment for HER2-expressing locally advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) (Hall 6 - Poster area) - Jul 18, 2024 - Abstract #ESMO2024ESMO_3154;
- Yutuo (zimberelimab) / Arcus Biosci, Gilead, Aidixi (disitamab vedotin) / Pfizer
Disitamab Vedotin and Zimberelimab combined with Stereotactic Body Radiation Therapy for the Treatment of Recurrent, Metastatic Cervical Cancer: A Single-Arm, Open-Label, Phase II Study (Hall 6 - Poster area) - Jul 18, 2024 - Abstract #ESMO2024ESMO_2552;
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
A Randomized, Multicenter, Open-Label Phase II Neoadjuvant Study to Evaluate the Safety and Efficacy of HER2-ADC Disitamab Vedotin in Combination Toripalimab or Sequence Chemotherapy in Participants With HR-negative, HER2 Low-expressing Breast Cancer (Hall 6 - Poster area) - Jul 18, 2024 - Abstract #ESMO2024ESMO_2244;
- | Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Combination therapy, Metastases: A prospective, single-arm, single-center clinical study of disitamab vedotin in combination with toripalimab in patients with advanced penile cancer that has progressed or is intolerant to cisplatin chemotherapy (EUDRACT) - Jul 16, 2024
P2, N=10, Recruiting, Sponsor: Chongqing University Cancer Hospital; Chongqing University Cancer Hospital
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion: A Multicenter, Prospective, Open-Label Study of Disitamab Vedotin in Neoadjvant Treatment of HER2 Positive Breast Cancer With Poor Early Efficacy (EUDRACT) - Jul 16, 2024
P2, N=20, Completed, Sponsor: The First Affiliated Hospital of Army Medical University, PLA; The First Affiliated Hospital of Army Medical University, PLA
RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters. Not yet recruiting --> Completed
- Keytruda (pembrolizumab) / Merck (MSD), Aidixi (disitamab vedotin) / Pfizer
Preliminary Efficacy And Safety Of Disitamab Vedotin (DV) With Pembrolizumab (P) In Treatment (Tx)-Naive HER2-Expressing, Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC): RC48G001 Cohort C (Bilbao Auditorium - Hall 2) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1599;
- | Tai'ai (telitacicept) / Rongchang Pharma
Biomarker, New trial, Real-world evidence, Real-world: Exploring the efficacy, safty, and biomarkers in the treatment of Neuroimmune Diseases with Telitacicept (Tai Ai (EUDRACT) - Jul 15, 2024
P=N/A, N=60, Not yet recruiting, Sponsor: Linyi People's Hospital; Linyi People's Hospital
- | Tai'ai (telitacicept) / Rongchang Pharma
New trial: Efficacy and safety of telitacicept in the treatment of primary IgA nephropathy: a prospective cohort study (EUDRACT) - Jul 15, 2024
P=N/A, N=100, Not yet recruiting, Sponsor: The Second Hospital of Shanxi Medical University; The Second Hospital of Shanxi Medical University
- | Tai'ai (telitacicept) / Rongchang Pharma
New trial: A multicenter prospective randomized controlled study on the treatment of primary IgA nephropathy with recombinant human B lymphocyte stimulatory factor receptor antibody fusion protein (Telitacicept) (EUDRACT) - Jul 15, 2024
P=N/A, N=90, Recruiting, Sponsor: Ningxia Medical University General; Ningxia Medical University General
- | Tai'ai (telitacicept) / Rongchang Pharma
New P4 trial: Efficacy and safety of telitacicept for patients with systemic sclerosis in clinical practice: a single-center, single-arm, open-label study (EUDRACT) - Jul 15, 2024
P4, N=8, Completed, Sponsor: Ningbo Medical Center Lihuili Hospital; Ningbo Medical Center Lihuili Hospital
- | Avastin (bevacizumab) / Roche, Aidixi (disitamab vedotin) / Pfizer
New P4 trial: Distamab Vedotin combined with carboplatin and bevacizumab for HER2-expressing platinum-sensitive ovarian cancer with prior PARPi treatment: a single arm, phase II study. (EUDRACT) - Jul 15, 2024
P4, N=39, Not yet recruiting, Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
- | Tai'ai (telitacicept) / Rongchang Pharma
New P4 trial: Efficacy and safety of Telitacicept in the treatment of recurrent IgA nephropathy after transplantation (EUDRACT) - Jul 15, 2024
P4, N=40, Not yet recruiting, Sponsor: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; Tongji Hospital Affiliated to Tongji Medical Co
- | Tai'ai (telitacicept) / Rongchang Pharma
New P4 trial: Study on the Salvage Treatment of Chronic Antibody Mediated Rejection after Renal Transplantation with Telitacicept (EUDRACT) - Jul 15, 2024
P4, N=10, Not yet recruiting, Sponsor: Xiangya Hospital of Central South University; Xiangya Hospital of Central South University
- | Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: Effect of Telitacicept on skin damage and related cytokine levels in patients with Systemic Lupus Erythematosus (EUDRACT) - Jul 15, 2024
P2, N=50, Recruiting, Sponsor: Department of Dermatology, Second Affiliated Hospital of Xi 'an Jiaotong University; Xi 'an Jiaotong University Second Affiliated Hospital
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial: Evaluation of the efficacy and safety of disitamab vedotin as neoadjuvant therapy in patients with stage T3-T4a bladder cancer: a single-centre, single-arm, open-label, phase II clinical study (EUDRACT) - Jul 15, 2024
P2, N=125, Not yet recruiting, Sponsor: Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University
- | Aidixi (disitamab vedotin) / Pfizer
New P2 trial: A single-arm, single-center, phase II clinical study to evaluate the efficacy and safety of Disitamab Vedotin in patients with metastatic castration-resistant prostate cancer ( mCRPC ) after standard treatment failure (EUDRACT) - Jul 15, 2024
P2, N=20, Not yet recruiting, Sponsor: Jiangxi Cancer Hospital; Jiangxi Cancer Hospital
- | Tai'ai (telitacicept) / Rongchang Pharma, Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
New P2 trial: A Study on the Efficacy and Safety of Sequential Efgartigimod and Telitacicept Therapy in the Treatment of Generalized Myasthenia Gravis (EUDRACT) - Jul 15, 2024
P2, N=30, Not yet recruiting, Sponsor: Peking University People's Hospital; Peking University People's Hospital
- | Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: A Study on the Efficacy and Safety of Telitacicept Treatment versus Tacrolimus Treatment in Newly Diagnosed AchR-Positive Generalized Myasthenia Gravis (EUDRACT) - Jul 15, 2024
P2, N=124, Not yet recruiting, Sponsor: Peking University People's Hospital; Peking University People's Hospital
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial: Efficacy and safety of Disitamab Vedotin in the treatment of HER2-expressing or amplified head and neck carcinomas:a single-arm phase II clinical study (EUDRACT) - Jul 15, 2024
P2, N=30, Recruiting, Sponsor: Zhejiang Tumor Hospital; Zhejiang Tumor Hospital
- | Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: Population pharmacokinetic study of Telitacicept in children with lupus nephritis (EUDRACT) - Jul 15, 2024
P2, N=50, Not yet recruiting, Sponsor: Children
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial: A prospective, single-arm, single-center, phase II clinical study of disitamab vedotin in patients with advanced rare malignant tumors expressing HER2 who failed standard therapy (EUDRACT) - Jul 15, 2024
P2, N=30, Not yet recruiting, Sponsor: Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital
- | Aidixi (disitamab vedotin) / Pfizer
New P2 trial: Perioperative chemotherapy plus Disitamab vedotin and PD-1 antibody in HER2-overexpression locally advanced gastric, or gastro-esophageal junction cancer: an open-label, phase 2 trial (EUDRACT) - Jul 15, 2024
P2, N=44, Not yet recruiting, Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center