 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- | Trial primary completion date: FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - Dec 27, 2024
P2, N=716, Recruiting, Sponsor: Fudan University
Trial primary completion date: Sep 2024 --> Dec 2024
- | tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma, Ariely (adebrelimab) / Jiangsu Hengrui Pharma
Trial initiation date: Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - Dec 20, 2024
P2, N=32, Not yet recruiting, Sponsor: Fudan University
Trial primary completion date: Sep 2024 --> Dec 2024 Initiation date: Jul 2024 --> Dec 2024
- | Enrollment change: Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - Dec 19, 2024
P2, N=10, Recruiting, Sponsor: Peking Union Medical College
Initiation date: Jul 2024 --> Dec 2024 N=30 --> 10
- | New P2 trial: Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov) - Oct 17, 2024
P2, N=120, Recruiting, Sponsor: Fudan University
- | Enrollment change: BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) - Oct 4, 2024
P2, N=620, Recruiting, Sponsor: Fudan University
N=30 --> 10 N=140 --> 620
- ||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment closed, Enrollment change, Combination therapy, Metastases: SHR-A1921-201: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Sep 26, 2024
P1/2, N=220, Active, not recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
N=140 --> 620 Recruiting --> Active, not recruiting | N=120 --> 220
- | New P2 trial: The conversion therapy for the stage III unresectable non-small cell lung cancer: a patient-oriented, prospective, open-label, multicentric, umbrella, phase II clinical trial (EUDRACT) - Sep 20, 2024
P2, N=165, Recruiting, Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital
- ||| HRS-4642 / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy, Metastases: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - Sep 2, 2024
P1/2, N=70, Enrolling by invitation, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Recruiting --> Active, not recruiting | N=120 --> 220 Not yet recruiting --> Enrolling by invitation
- |||||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open: SHR-A1921-303: SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - Aug 9, 2024
P3, N=440, Recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Not yet recruiting --> Enrolling by invitation Not yet recruiting --> Recruiting
- | Phase classification: FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - Aug 6, 2024
P2, N=716, Recruiting, Sponsor: Fudan University
Not yet recruiting --> Recruiting Phase classification: P1/2 --> P2
- SHR-A1921 / Jiangsu Hengrui Pharma
SHR-A1921, A TROP-2 Targeted Antibody-Drug Conjugate (ADC), In Patients (pts) with Advanced Small-Cell Lung Cancer (SCLC) (20A) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_844;
P1
No TRAEs led to treatment discontinuation or death. Conclusions : SHR-A1921 showed promising clinical efficacy and a manageable safety profile in pts with heavily pretreated extensive-stage SCLC, even with low TROP-2 expression.
- | Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New trial, Metastases: An exploratory study of SHR-A1921 combined with S-1 for patients with advanced pancreatic cancer (EUDRACT) - Jul 15, 2024
P=N/A, N=45, Not yet recruiting, Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
- | tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma, Ariely (adebrelimab) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: An exploratory clinical study of SHR-A1921 combined with adebrelimab in the treatment of advanced NSCLC who failed the previous standard first-line treatment (EUDRACT) - Jul 15, 2024
P2, N=32, Not yet recruiting, Sponsor: shanghai pulmonary hospital; shanghai pulmonary hospital
- | tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma, Ariely (adebrelimab) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment (clinicaltrials.gov) - Jun 28, 2024
P2, N=32, Not yet recruiting, Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
- |||| SHR-9839 / Jiangsu Hengrui Pharma
New P1/2 trial, Combination therapy, Metastases: A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 25, 2024
P1/2, N=156, Not yet recruiting, Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
- || tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Trial completion, Trial completion date, Trial primary completion date: SHR-A1921-I-102-AUS: A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Jun 25, 2024
P1, N=9, Completed, Sponsor: Atridia Pty Ltd.
Conclusions : SHR-A1921 showed promising clinical efficacy and a manageable safety profile in pts with heavily pretreated extensive-stage SCLC, even with low TROP-2 expression. Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
- | tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma, Ariely (adebrelimab) / Jiangsu Hengrui Pharma
New P2 trial: Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - Jun 23, 2024
P2, N=32, Not yet recruiting, Sponsor: Fudan University
- | SHR-A2009 / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC (clinicaltrials.gov) - Jun 18, 2024
P2, N=30, Not yet recruiting, Sponsor: Henan Cancer Hospital
- | Ariely (adebrelimab) / Jiangsu Hengrui Pharma
New P2 trial: Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - May 30, 2024
P2, N=131, Not yet recruiting, Sponsor: Beijing GoBroad Hospital
- |||| New P1/2 trial, Combination therapy, Metastases: SHR-A1921-205: Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC (clinicaltrials.gov) - May 29, 2024
P1/2, N=124, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- |||||||||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P3 trial: SHR-A1921-303: SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - May 1, 2024
P3, N=440, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- |||| HRS-4642 / Jiangsu Hengrui Pharma
New P1/2 trial, Combination therapy, Metastases: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - Apr 26, 2024
P1/2, N=70, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, SHR-A1921 / Jiangsu Hengrui Pharma
A phase II umbrella clinical trial of advanced salivary gland cancer based on molecular typing. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6678;
P2
This molecular subtype-guided precision therapy for advanced salivary gland cancer showed promising results with acceptable toxicity. Clinical trial information: NCT05924256.
- | Trial initiation date: Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - Mar 21, 2024
P2, N=30, Recruiting, Sponsor: Peking Union Medical College
Clinical trial information: NCT05924256. Initiation date: Dec 2023 --> May 2024
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment change, Metastases: A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - Mar 15, 2024
P2, N=88, Recruiting, Sponsor: Fudan University
Initiation date: Dec 2023 --> May 2024 N=66 --> 88
- | Avastin (bevacizumab) / Roche, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P2 trial: SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases (clinicaltrials.gov) - Jan 18, 2024
P2, N=24, Not yet recruiting, Sponsor: Fudan University
- |||||||||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P2/3 trial: SHR-A1921-301: A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer (clinicaltrials.gov) - Jan 18, 2024
P2/3, N=520, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- || tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment closed, Enrollment change: SHR-A1921-I-102-AUS: A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Dec 27, 2023
P1, N=9, Active, not recruiting, Sponsor: Atridia Pty Ltd.
N=66 --> 88 Recruiting --> Active, not recruiting | N=35 --> 9
- | New P2 trial: Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - Nov 27, 2023
P2, N=30, Recruiting, Sponsor: Peking Union Medical College
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open, Trial completion date, Trial primary completion date, Metastases: A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - Aug 2, 2023
P2, N=66, Recruiting, Sponsor: Fudan University
Recruiting --> Active, not recruiting | N=35 --> 9 Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - Jun 29, 2023
P2, N=66, Not yet recruiting, Sponsor: Fudan University
- ||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy, Metastases: SHR-A1921-201: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 10, 2023
P1/2, N=120, Recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025 Not yet recruiting --> Recruiting
- SHR-A1921 / Jiangsu Hengrui Pharma
A first-in-human (FIH) phase 1 study of SHR-A1921, a TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors (Section 45; Poster Board #13) - Mar 14, 2023 - Abstract #AACR2023AACR_6004;
P1
SHR-A1921 showed a manageable safety profile and promising anti-tumor activity in patients with pretreated advanced cancer. The trial is ongoing to assess SHR-A1921 at different dosing frequency and the efficacy in selected cancer types.
- SHR-A1921 / Jiangsu Hengrui Pharma
SHR-A1921, a novel TROP-2 ADC with an optimized design and well-balanced profile between efficacy and safety (Section 35; Poster Board #22) - Mar 14, 2023 - Abstract #AACR2023AACR_2086;
P1
#. non-head-to-head comparison.)
- |||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P1/2 trial, Combination therapy, Metastases: SHR-A1921-201: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 13, 2023
P1/2, N=120, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- | Enrollment open: FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - Feb 6, 2023
P1/2, N=716, Recruiting, Sponsor: Fudan University
non-head-to-head comparison.) Not yet recruiting --> Recruiting
- | Enrollment open: BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) - Jan 4, 2023
P2, N=140, Recruiting, Sponsor: Fudan University
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open: SHR-A1921-I-102-AUS: A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Dec 1, 2022
P1, N=35, Recruiting, Sponsor: Atridia Pty Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | New P2 trial: BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) - Oct 26, 2022
P2, N=140, Not yet recruiting, Sponsor: Fudan University
- || tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P1 trial: SHR-A1921-I-102-AUS: A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Oct 26, 2022
P1, N=35, Not yet recruiting, Sponsor: Atridia Pty Ltd.
- | New P1/2 trial: FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - Oct 17, 2022
P1/2, N=716, Not yet recruiting, Sponsor: Fudan University
- ||| tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
New P1 trial: SHR-A1921-I-101: A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - Dec 12, 2021
P1, N=156, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.