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- || Aidixi (disitamab vedotin) / Pfizer
Trial completion, Enrollment change, Metastases: C001 CANCER: A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Aug 8, 2020
P1, N=24, Completed, Sponsor: RemeGen
Recruiting --> Completed | N=50 --> 24
- || Aidixi (disitamab vedotin) / Pfizer
Trial initiation date, Metastases: A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov) - Aug 7, 2020
P2, N=57, Recruiting, Sponsor: RemeGen
Recruiting --> Completed | N=50 --> 24 Initiation date: Apr 2020 --> Aug 2020
- || RC28-E / Rongchang
PK/PD data, Preclinical, Journal: In vivo characterization of RC28-E, a fusion protein targeting VEGF and bFGF: Pharmacokinetics and ocular distribution in primates. (Pubmed Central) - Jul 19, 2020
No drug accumulation after multiple administration was noticed, but low titers of antibody produce against RC28-E were detected. Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy.
- || misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Jun 11, 2020
P1, N=31, Recruiting, Sponsor: RemeGen
Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy. Not yet recruiting --> Recruiting
- || Aidixi (disitamab vedotin) / Pfizer
Enrollment closed, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2 (clinicaltrials.gov) - Jun 9, 2020
P2, N=127, Active, not recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||| Aidixi (disitamab vedotin) / Pfizer
Trial completion, Trial completion date, Trial primary completion date, Metastases: Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors (clinicaltrials.gov) - Jun 4, 2020
P1, N=57, Completed, Sponsor: RemeGen
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019 | Trial primary completion date: May 2020 --> Jun 2019
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P3 trial, Metastases: RC48-C012: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov) - May 22, 2020
P3, N=366, Not yet recruiting, Sponsor: RemeGen
- ||| Aidixi (disitamab vedotin) / Pfizer
Enrollment change, Metastases: C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - May 18, 2020
P1/2, N=90, Recruiting, Sponsor: RemeGen
Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019 | Trial primary completion date: May 2020 --> Jun 2019 N=165 --> 90
- ||||| telitacicept (RC18) / Rongchang
Fast track designation: FDA Grants Fast Track Designation to Telitacicept as a Treatment for #SLE. Telitacicept is a recombinant fusion protein of TACI receptor & the Fc domain of IgG1, inhibiting B cell activity by neutralizing BLyS and APRIL. + results at #ACR2019 https://t.co/7ndMWb2Rjf (Twitter) - Apr 15, 2020
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov) - Apr 1, 2020
P2, N=57, Recruiting, Sponsor: RemeGen
- || Aidixi (disitamab vedotin) / Pfizer
New P1/2 trial, Metastases: A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Mar 16, 2020
P1/2, N=36, Recruiting, Sponsor: RemeGen
- || Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: A Study of TACI?Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor?-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis (clinicaltrials.gov) - Mar 10, 2020
P2, N=20, Recruiting, Sponsor: RemeGen
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. (clinicaltrials.gov) - Mar 5, 2020
P3, N=480, Recruiting, Sponsor: RemeGen
N=165 --> 90 Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion, Trial completion date, Trial primary completion date: Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) - Mar 4, 2020
P2b, N=249, Completed, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jun 2019
- | RC28-E / Rongchang Pharma
Trial completion date, Trial primary completion date: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Mar 4, 2020
P1, N=12, Recruiting, Sponsor: RemeGen
Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jun 2019 Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020
- || Aidixi (disitamab vedotin) / Pfizer
Trial primary completion date, Metastases: C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - Mar 2, 2020
P1/2, N=165, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020 Trial primary completion date: Jan 2020 --> Aug 2020
- || Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy (clinicaltrials.gov) - Mar 1, 2020
P2, N=30, Recruiting, Sponsor: RemeGen
- | Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: C001 CANCER: A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 27, 2020
P1, N=50, Recruiting, Sponsor: RemeGen
Trial primary completion date: Jan 2020 --> Aug 2020 Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 27, 2020
P1, N=57, Active, not recruiting, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020 Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2017 --> May 2020
- || Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
New P1 trial, Combination therapy, Metastases: JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 20, 2020
P1, N=50, Not yet recruiting, Sponsor: Peking University
- || RC28-E / Rongchang Pharma
New P1/2 trial: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Feb 16, 2020
P1/2, N=36, Recruiting, Sponsor: RemeGen
- ||| Aidixi (disitamab vedotin) / Pfizer
Enrollment change, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2 (clinicaltrials.gov) - Feb 13, 2020
P2, N=125, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2017 --> May 2020 N=72 --> 125
- | Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Pfizer
New P1/2 trial, Metastases: RC48-C014: A Study of RC48-ADC(Antibody Drug Conjugate) and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Feb 10, 2020
P1/2, N=36, Recruiting, Sponsor: Beijing Cancer Hospital
- || Tai'ai (telitacicept) / Rongchang Pharma
New P1 trial: A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects (clinicaltrials.gov) - Jan 22, 2020
P1, N=36, Completed, Sponsor: RemeGen
- || Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial primary completion date, Metastases: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov) - Jan 7, 2020
P2, N=228, Recruiting, Sponsor: RemeGen
N=72 --> 125 Trial primary completion date: Dec 2019 --> Jul 2020
- || RC98 / Rongchang Pharma
New P1 trial, Metastases: A Study of RC98 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Dec 8, 2019
P1, N=25, Not yet recruiting, Sponsor: RemeGen
- || misitatug blivedotin (RC88) / Rongchang Pharma
New P1 trial, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Nov 24, 2019
P1, N=31, Not yet recruiting, Sponsor: RemeGen
- | Tai'ai (telitacicept) / Rongchang Pharma
New P3 trial: Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) - Sep 9, 2019
P3, N=318, Recruiting, Sponsor: RemeGen
- | Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sj (clinicaltrials.gov) - Sep 5, 2019
P2, N=30, Recruiting, Sponsor: RemeGen
- | Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Aug 29, 2019
P2, N=20, Recruiting, Sponsor: RemeGen
- | Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: C001 CANCER: A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Aug 22, 2019
P1, N=50, Recruiting, Sponsor: RemeGen
Trial primary completion date: Dec 2019 --> Jul 2020 Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019
- | Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed, Enrollment change: Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) - Jul 18, 2019
P2b, N=249, Active, not recruiting, Sponsor: RemeGen
Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019 Recruiting --> Active, not recruiting | N=160 --> 249
- | Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2 (clinicaltrials.gov) - Jul 18, 2019
P2, N=72, Recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting | N=160 --> 249 Trial completion date: Dec 2019 --> Aug 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- || Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion, Trial completion date, Trial primary completion date, Metastases: RC48-C005: A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer (clinicaltrials.gov) - Jun 26, 2019
P2, N=43, Completed, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Aug 2020 | Trial primary completion date: Jun 2019 --> Jun 2020 Recruiting --> Completed | Trial completion date: Dec 2020 --> Oct 2018 | Trial primary completion date: Dec 2019 --> Oct 2018
- || Aidixi (disitamab vedotin) / Pfizer
Enrollment closed, Trial completion date, Metastases: Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors (clinicaltrials.gov) - May 16, 2019
P1, N=57, Active, not recruiting, Sponsor: RemeGen
Recruiting --> Completed | Trial completion date: Dec 2020 --> Oct 2018 | Trial primary completion date: Dec 2019 --> Oct 2018 Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2019
- ||||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial termination, Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-? Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis (clinicaltrials.gov) - Apr 3, 2019
P2, N=60, Terminated, Sponsor: RemeGen
Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2019 Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Dec 2019 --> Feb 2019; Lack of trial population, unable to recruit subjects
- | Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: C001 CANCER: A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Jan 18, 2019
P1, N=50, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Dec 2019 --> Feb 2019; Lack of trial population, unable to recruit subjects Trial completion date: Aug 2018 --> Aug 2019 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: RC48-C009: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Jan 18, 2019
P2, N=60, Recruiting, Sponsor: RemeGen
- | RC28-E / Rongchang Pharma
Trial primary completion date: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Jan 17, 2019
P1, N=12, Recruiting, Sponsor: RemeGen
Trial completion date: Aug 2018 --> Aug 2019 | Trial primary completion date: Jun 2018 --> Jun 2019 Trial primary completion date: Dec 2018 --> Dec 2019
- || RC28-E / Rongchang Pharma
New P1 trial: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Dec 17, 2018
P1, N=12, Recruiting, Sponsor: RemeGen
- | Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-? Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis (clinicaltrials.gov) - Aug 29, 2018
P2, N=60, Recruiting, Sponsor: RemeGen
Trial primary completion date: Dec 2018 --> Dec 2019 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2 (clinicaltrials.gov) - Jun 13, 2018
P2, N=72, Recruiting, Sponsor: RemeGen
- ||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial, Metastases: RC48-C005: A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer (clinicaltrials.gov) - Apr 23, 2018
P2, N=60, Recruiting, Sponsor: RemeGen
- ||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial, Metastases: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov) - Apr 18, 2018
P2, N=228, Recruiting, Sponsor: RemeGen
- || Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) - Apr 11, 2018
P2b, N=160, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Trial completion date: Dec 2017 --> Dec 2019 | Trial primary completion date: Sep 2017 --> Dec 2019
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
New P3 trial: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - Nov 6, 2017
P3, N=118, Recruiting, Sponsor: RemeGen
- || Tai'ai (telitacicept) / Rongchang Pharma
Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-? Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis (clinicaltrials.gov) - Aug 2, 2017
P2, N=60, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2017 --> Dec 2019 | Trial primary completion date: Sep 2017 --> Dec 2019 Trial primary completion date: Jun 2017 --> Dec 2018
- Aidixi (disitamab vedotin) / Pfizer
Trial primary completion date, Metastases: C001 CANCER: A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - Aug 2, 2017
P1, N=50, Recruiting, Sponsor: RemeGen
Trial primary completion date: Jun 2017 --> Dec 2018 Trial primary completion date: Jun 2017 --> Jun 2018
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. (clinicaltrials.gov) - Aug 2, 2017
P3, N=480, Recruiting, Sponsor: RemeGen
Trial primary completion date: Jun 2017 --> Jun 2018 Trial primary completion date: Jun 2017 --> Dec 2019
- Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial primary completion date, Metastases: Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 23, 2017
P1, N=50, Recruiting, Sponsor: RemeGen
Trial primary completion date: Jun 2017 --> Dec 2019 Trial primary completion date: Dec 2016 --> Dec 2017