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- || trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
P1 data, PK/PD data, Journal, Metastases: Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. (Pubmed Central) - Jun 20, 2024
SHR-A1811 exhibited acceptable tolerability, promising antitumor activity, and a favorable pharmacokinetic profile in heavily pretreated advanced solid tumors. The recommended phase II dose of 4.8 or 6.4 mg/kg was selected for various tumor types.
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer (clinicaltrials.gov) - May 14, 2024
P2, N=65, 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.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Efficacy and safety of HER2-ADC SHR-A1811 in HER2-positive breast cancer with brain metastases. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6208;
P2
Clinical trial information: NCT05924256. Patients with radiotherapy-na
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, adebrelimab (SHR-1316) / Jiangsu Hengrui Pharma
New P2 trial, Combination therapy: SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer (clinicaltrials.gov) - Apr 1, 2024
P2, N=93, Not yet recruiting, Sponsor: Shengjing Hospital
- || trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors (clinicaltrials.gov) - Mar 21, 2024
P1, N=101, Active, not recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Patients with radiotherapy-na Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, 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
Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Jun 2024 N=66 --> 88
- SHR-4602 / Jiangsu Hengrui Pharma
SHR-4602, next generation of HER2-targeting ADC with potent anti-tumor efficacy overcoming the resistance of HER2 ADC with Topo I inhibitor payload in xenograft models (Section 23) - Mar 5, 2024 - Abstract #AACR2024AACR_5329;
P1
SHR-4602 represents a new generation HER2-targeting ADC to deliver a potent cytotoxin to HER2 expressing tumor cells and may be more efficacious to the tumors in which current anti-HER2 therapies are ineffective. SHR-4602 is now in the phase I clinical development stage for advanced malignant solid tumors (NCT05819684).
- HRA00242-C004 / Jiangsu Hengrui Pharma
HRA00242-C004, a novel anti-PSMA ADC with high DAR reveals potent in vitro and in vivo anti-tumor efficacy (Section 21) - Mar 5, 2024 - Abstract #AACR2024AACR_5312;
2006; 30: 628-36.5.Front Oncol. 2018; 8: 653-63.
- |||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open, Metastases: SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen (clinicaltrials.gov) - Jan 16, 2024
P3, N=360, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
2018; 8: 653-63. Not yet recruiting --> Recruiting
- |||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P3 trial, Metastases: Injection of SHR-A1811 Versus TAS-102 in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan (clinicaltrials.gov) - Jan 11, 2024
P3, N=96, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open: A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov) - Dec 20, 2023
P2, N=66, Recruiting, Sponsor: Henan Cancer Hospital
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P3 trial: A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy (clinicaltrials.gov) - Nov 13, 2023
P3, N=1200, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P3 trial, Metastases: SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen (clinicaltrials.gov) - Nov 8, 2023
P3, N=360, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Avastin (bevacizumab) / Roche, AiRuiKa (camrelizumab) / HLB Bio Group
Enrollment open: FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov) - Nov 1, 2023
P2, N=120, Recruiting, Sponsor: Fudan University
Active, not recruiting --> Recruiting Not yet recruiting --> Recruiting
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment change, Metastases: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov) - Oct 19, 2023
P2, N=100, Recruiting, Sponsor: Henan Cancer Hospital
Not yet recruiting --> Recruiting N=75 --> 100
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma, adebrelimab (SHR-1316) / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy, Metastases: A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Oct 16, 2023
P1/2, N=324, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
N=75 --> 100 Not yet recruiting --> Recruiting
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment closed: A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov) - Sep 28, 2023
P2, N=66, Active, not recruiting, Sponsor: Henan Cancer Hospital
Not yet recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, 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
Not yet recruiting --> Active, not recruiting 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
Enrollment open, Metastases: A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression. (clinicaltrials.gov) - Aug 1, 2023
P1/2, N=116, 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
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Phase I trial of SHR-A1811 in HER2-expressing advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) and colorectal cancer (CRC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2257;
P1
Table: 684P Efficacy outcomes Conclusions SHR-A1811 showed an acceptable safety profile and promising clinical activity in pts with HER2-expressing GC/GEJ and CRC. Further investigation was warranted.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
The HER2-targeting ADC SHR-A1811 in HER2-expressing/mutated advanced non-breast solid tumors (STs): Results from the global phase I study (Valencia Auditorium - Hall 10) - Jul 27, 2023 - Abstract #ESMO2023ESMO_1367;
P1
Background SHR-A1811 is a novel ADC composed of trastuzumab (anti-HER2), a cleavable linker, and a topoisomerase I inhibitor payload, with optimized drug-antibody ratio of 6 and strong bystander killing effect. Table: 656MO ORR by tumor type and HER2 status BTC (N=22) UC (N=23) GC/GEJA (N=13) CRC (N=14) Other tumors (N=26) ORR*, n/N (%)(95% CI) 9/15 (60.0%)(32.3
- |||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open, Metastases: SHR-A1811-III-306: SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial (clinicaltrials.gov) - Jul 20, 2023
P3, N=530, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Table: 656MO ORR by tumor type and HER2 status BTC (N=22) UC (N=23) GC/GEJA (N=13) CRC (N=14) Other tumors (N=26) ORR*, n/N (%)(95% CI) 9/15 (60.0%)(32.3 Not yet recruiting --> Recruiting
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, 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
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P2 trial: A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov) - Jun 22, 2023
P2, N=66, Not yet recruiting, Sponsor: Henan Cancer Hospital
- ||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P2 trial: A Study of SHR-A1811 in Subjects With Gynaecologic Oncology (clinicaltrials.gov) - Jun 9, 2023
P2, N=225, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- || trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Trial primary completion date, Metastases: A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - May 10, 2023
P1/2, N=153, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Not yet recruiting --> Recruiting Trial primary completion date: Jan 2023 --> May 2023
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P1/2 trial: A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression. (clinicaltrials.gov) - May 6, 2023
P1/2, N=116, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P1/2 trial, Metastases: Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer?GALAXY? (clinicaltrials.gov) - Apr 21, 2023
P1/2, N=56, Active, not recruiting, Sponsor: Fudan University
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open, Metastases: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov) - Apr 18, 2023
P2, N=75, Recruiting, Sponsor: Henan Cancer Hospital
Trial primary completion date: Jan 2023 --> May 2023 Not yet recruiting --> Recruiting
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P3 trial, Metastases: SHR-A1811-III-306: SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial (clinicaltrials.gov) - Apr 14, 2023
P3, N=528, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- ||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open, Metastases: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer (clinicaltrials.gov) - Apr 7, 2023
P2, N=156, Recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P1/2 trial, Metastases: A Phase ?b/? Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer. (clinicaltrials.gov) - Mar 31, 2023
P1/2, N=300, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- ||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients (clinicaltrials.gov) - Mar 21, 2023
P2, N=61, Recruiting, Sponsor: Shengjing Hospital
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Nov 2028 --> Feb 2029 | Initiation date: Nov 2022 --> Mar 2023 | Trial primary completion date: Nov 2023 --> Feb 2024
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov) - Mar 15, 2023
P2, N=75, Not yet recruiting, Sponsor: Henan Cancer Hospital
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811, an antibody-drug conjugate, in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC): a multicenter, open-label, phase 1/2 study (Section 46; Poster Board #17) - Mar 14, 2023 - Abstract #AACR2023AACR_6024;
P1/2
SHR-A1811 showed tolerable safety profile and durable antitumor activity in heavily pretreated patients with HER2-mutant NSCLC. Dose expansion at 4.8 mg/kg and 5.6 mg/kg is ongoing to establish the RP2D.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (Section 45; Poster Board #7) - Mar 14, 2023 - Abstract #AACR2023AACR_5998;
Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)?381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35, 63.1-91.6)100% (1/1, 2.5-100)80.6% (29/36, 64.0-91.8)T-DM182.4% (14/17, 56.6-96.2)100% (3/3, 29.2-100)85.0% (17/20, 62.1-96.8)Other HER2-ADC (except T-DM1)**60.0% (9/15, 32.3-83.7)50.0% (2/4, 6.8-93.2)57.9% (11/19, 33.5-79.8)ORR in pts with tumor types other than BC (N=65)HER2 IHC3+ or IHC2+/ISH+ (N=36)HER2 IHC2+/ISH- or IHC1+ or unknown (N=29)All other tumor types (N=65)% (n/N)38.9% (14/36)31.0% (9/29)35.4% (23/65)ORR was shown as % (n/N, 95% CI) or % (n/N).
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
SHR-A1811, a novel anti-HER2 ADC with superior bystander effect, optimal DAR and favorable safety profiles (Section 35; Poster Board #23) - Mar 14, 2023 - Abstract #AACR2023AACR_2087;
P1/2, P2,
Here we presented a potential best-in-class HER2-directed ADC, SHR-A1811, which was composed of trastuzumab, a stable and cleavable linker, and a novel topoisomerase I inhibitor payload (SHR9265)...In summary, with a highly permeable payload, optimized DAR, great potency and better clinical safety profiles, SHR-A1811 has demonstrated the best-in-class potential. Currently SHR-A1811 has entered phase II and phase III clinical studies for breast cancer, gastric cancer, colorectal cancer, and NSCLC (NCT05424835, NCT05482568, NCT04818333, NCT05349409).
- | trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Avastin (bevacizumab) / Roche, AiRuiKa (camrelizumab) / HLB Bio Group
New P2 trial: FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov) - Mar 1, 2023
P2, N=120, Not yet recruiting, Sponsor: Fudan University
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma, adebrelimab (SHR-1316) / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy: A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer (clinicaltrials.gov) - Feb 21, 2023
P2, N=402, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Currently SHR-A1811 has entered phase II and phase III clinical studies for breast cancer, gastric cancer, colorectal cancer, and NSCLC (NCT05424835, NCT05482568, NCT04818333, NCT05349409). Not yet recruiting --> Recruiting
- | 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
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P2 trial, Metastases: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer (clinicaltrials.gov) - Jan 5, 2023
P2, N=156, Not yet recruiting, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- | Enrollment open, Metastases: 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
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma
New P2 trial: A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients (clinicaltrials.gov) - Dec 2, 2022
P2, N=61, Not yet recruiting, Sponsor: Shengjing Hospital
- | New P2 trial, Metastases: 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
- | 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
- |||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy, Metastases: A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane (clinicaltrials.gov) - Aug 10, 2022
P3, N=269, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma, adebrelimab (SHR-1316) / Jiangsu Hengrui Pharma
New P1/2 trial, Combination therapy, Metastases: A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 1, 2022
P1/2, N=324, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- |||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma
Enrollment open, Combination therapy, Metastases: A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers (clinicaltrials.gov) - Jun 30, 2022
P2, N=212, Enrolling by invitation, Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Enrolling by invitation
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
New P3 trial, Combination therapy, Metastases: A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane (clinicaltrials.gov) - Jun 21, 2022
P3, N=269, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.