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2ms
A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P1/2, N=130, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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izalontamab (SI-B001) • danvilostomig (SI-B003)
2ms
A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=42, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=30 --> 42
Enrollment closed • Enrollment change
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paclitaxel • izalontamab (SI-B001)
2ms
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
P1/2, N=160, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF mutation • BRAF V600 • EGFR wild-type • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
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izalontamab (SI-B001) • danvilostomig (SI-B003)
2ms
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
P2, N=69, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR wild-type • ALK wild-type
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cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
2ms
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
P1, N=60, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
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izalontamab (SI-B001)
2ms
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=22, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=40 --> 22
Enrollment closed • Enrollment change
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irinotecan • izalontamab (SI-B001)
2ms
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=11, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=30 --> 11
Enrollment closed • Enrollment change
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izalontamab (SI-B001)
2ms
SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
P2/3, N=14, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
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EGFR mutation
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Tagrisso (osimertinib) • izalontamab (SI-B001)
2ms
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
Trial completion date • Trial primary completion date
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irinotecan • izalontamab (SI-B001)
3ms
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers (clinicaltrials.gov)
P2, N=13, Terminated, Merus N.V. | N=90 --> 13 | Trial completion date: Mar 2026 --> Jul 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2025 --> Jul 2025; Merus terminated the study early due to changes in organizational priorities.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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NRG1 (Neuregulin 1)
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NRG1 fusion
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Gilotrif (afatinib) • Xtandi (enzalutamide) • abiraterone acetate • Bizengri (zenocutuzumab-zbco)
3ms
SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
P2/3, N=14, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
Trial completion date • Trial primary completion date
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EGFR mutation
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Tagrisso (osimertinib) • izalontamab (SI-B001)