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tizetatug rezetecan (SHR-A1921)
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Other names: SHR-A1921, SHRA1921, SHR A1921
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Company:
Jiangsu Hengrui Pharma
Drug class:
Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
Related drugs:
9d
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
P2, N=88, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting
Enrollment closed
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • AiRuiEn (rezvilutamide) • tizetatug rezetecan (SHR-A1921)
1m
TROP-2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: A first-in-human phase 1 study. (PubMed, Cancer Cell)
No significant correlation was found between TROP-2 expression and treatment efficacy. In summary, SHR-A1921 exhibited promising antitumor activity and a manageable safety profile, with 3.0 mg/kg every 3 weeks selected for further clinical development.
P1 data • Journal • First-in-human
|
TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HR positive
|
tizetatug rezetecan (SHR-A1921)
3ms
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Sep 2028 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Yidafan (ivonescimab) • AiRuiLi (adebrelimab) • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
7ms
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
P2, N=88, Recruiting, Fudan University | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Sep 2025 --> Dec 2025
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • AiRuiEn (rezvilutamide) • tizetatug rezetecan (SHR-A1921)
11ms
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Trial primary completion date: Sep 2024 --> Dec 2024
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • AiRuiLi (adebrelimab) • tizetatug rezetecan (SHR-A1921)
12ms
Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
P2, N=32, Not yet recruiting, Fudan University | Initiation date: Jul 2024 --> Dec 2024
Trial initiation date • Metastases
|
AiRuiLi (adebrelimab) • tizetatug rezetecan (SHR-A1921)
1year
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
P2, N=120, Recruiting, Fudan University
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HER-2 expression
|
trastuzumab rezetecan (SHR-A1811) • SHR-A2102 • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
1year
BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov)
P2, N=620, Recruiting, Fudan University | N=140 --> 620
Enrollment change
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
|
Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
1year
SHR-A1921-201: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=220, Active, not recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | N=120 --> 220
Enrollment closed • Enrollment change • Combination therapy • Metastases
|
Avastin (bevacizumab) • cisplatin • carboplatin • tizetatug rezetecan (SHR-A1921)
1year
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 (ChiCTR2400087339)
P2, N=165, Recruiting, Shanghai Chest Hospital; Shanghai Chest Hospital
New P2 trial
|
Loqtorzi (toripalimab-tpzi) • Ensacove (ensartinib) • Qi Xinke (iruplinalkib) • Semena (befotertinib) • bozitinib (APL-101) • AiRuiLi (adebrelimab) • tizetatug rezetecan (SHR-A1921)
over1year
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov)
P1/2, N=70, Enrolling by invitation, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Enrolling by invitation
Enrollment open • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
cisplatin • carboplatin • pemetrexed • AiRuiLi (adebrelimab) • HRS-4642 • tizetatug rezetecan (SHR-A1921)
over1year
SHR-A1921-303: SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov)
P3, N=440, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
paclitaxel • doxorubicin hydrochloride • topotecan • tizetatug rezetecan (SHR-A1921)
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