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20d
Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=33, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Trial termination • First-in-human
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ALK (Anaplastic lymphoma kinase) • GPC3 (Glypican 3)
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Tecentriq (atezolizumab) • SAR444200
27d
NWRD06 DNA Plasmid for HCC After Curative Resection. (clinicaltrials.gov)
P2, N=30, Recruiting, Newish Technology (Beijing) Co., Ltd.
New P2 trial
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GPC3 (Glypican 3)
1m
BANTAM-01: A Multicenter, Open-Label, First-in-Human Phase 1 Dose Escalation and Expansion Study of 225Ac-GPC3 (BAY 3547926) in Patients with Advanced Hepatocellular Carcinoma. (PubMed, J Nucl Med)
Study recruitment commenced in March 2025, and approximately 148 participants will be enrolled. The study will provide important preliminary insights on the efficacy and safety of 225Ac-GPC3 ACC therapy.
P1 data • Journal • First-in-human
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GPC3 (Glypican 3)
2ms
MTX-GPC3-303: A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC (clinicaltrials.gov)
P1, N=70, Recruiting, Myeloid Therapeutics | N=48 --> 70 | Trial completion date: May 2026 --> May 2028 | Trial primary completion date: Jul 2025 --> Dec 2027
Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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Avastin (bevacizumab) • Tecentriq (atezolizumab)
2ms
Organ-specific delivery of an mRNA-encoded bispecific T cell engager targeting glypican-3 in hepatocellular carcinoma. (PubMed, Nat Commun)
No severe adverse effects or gross pathology were observed. Our results thus support the advancement of MTS105 into clinical trials, with a first-in-human study currently underway.
Journal
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CD8 (cluster of differentiation 8) • GPC3 (Glypican 3)
2ms
New P1 trial
2ms
ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov)
P1/2, N=20, Recruiting, Eureka Therapeutics Inc. | Phase classification: P2 --> P1/2
Phase classification
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GPC3 (Glypican 3)
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cyclophosphamide • ECT204
4ms
Identification and non-clinical characterization of SAR444200, a novel anti-GPC3 NANOBODY® T-cell engager, for the treatment of GPC3+ solid tumors. (PubMed, Mol Cancer Ther)
The highly potent and efficacious activity of SAR444200 in diverse models of GPC3+ tumors and the extremely wide tolerated dose range merits further development of this compound. Furthermore, NANOBODY®-based TCEs developed using an anti-TCRαβ moiety may have specific advantages for the development of TCEs.
Journal • IO biomarker
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GPC3 (Glypican 3) • CD3E (CD3 Epsilon Subunit Of T-Cell Receptor Complex)
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SAR444200
4ms
Glypican-3: Novel Theranostic Agent for Hepatocellular Carcinoma. (PubMed, Semin Nucl Med)
First-in-human studies, including 124I-codrituzumab and 68Ga-RAYZ-8009, confirmed tumor-specific accumulation but remained limited in scale...The available evidence suggests a preferential pathway, involving the selection of a limited set of lead vectors, their pairing with suitable radionuclides, validation in orthotopic/PDX models using standardized endpoints, and the integration of comprehensive dosimetric and toxicologic studies before proceeding to broader human trials. GPC3-directed theranostics thus offers a compelling, disease-specific route to precision management of HCC, provided translational rigor addresses the outlined safety and quantitative imaging gaps.
Review • Journal
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GPC3 (Glypican 3)
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codrituzumab (RG7686)
6ms
ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov)
P2, N=20, Recruiting, Eureka Therapeutics Inc. | N=30 --> 20
Enrollment change
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GPC3 (Glypican 3)
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cyclophosphamide • Stivarga (regorafenib) • ECT204
7ms
Therapeutic Glypican-3 CRISPR Genome-Editing Using UltraLarge Porous Silica Nano-Depot for the Treatment of Hepatocellular Carcinoma. (PubMed, Small Sci)
Furthermore, the GPC3 CRISPR-Cas9@UPSND treatment exhibits superior anti-proliferative efficacy in tumor-growth prevention compared to Codrituzumab, as evidenced by the analysis of Ki67 and GPC3 expression, along with serum GPC3 levels. These findings underscore the translational potential of the non-viral UPSND nanoplatform-based CRISPR GPC3 genome editing, offering a promising targeted therapeutic strategy for HCC treatment.
Journal
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GPC3 (Glypican 3)
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codrituzumab (RG7686)
8ms
Engineered E. coli OMVs Carrying the Membrane-Binding hGC33 Fragment Precisely Target Liver Cancer and Effectively Treat Tumor. (PubMed, Int J Nanomedicine)
Meanwhile, hGC33-OMVs suppressed HepG2 cell proliferation, induced G1-phase arrest, and reduced Wnt3a, β-catenin, Cyclin D1, and C-myc expression. Engineered E. coli hGC33-OMVs effectively target HCC via the hGC33-GPC3 interaction, inhibit tumor growth by suppressing Wnt signaling, and demonstrate potential for use as a versatile platform for antibody delivery.
Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CCND1 (Cyclin D1) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • GPC3 (Glypican 3) • PCNA (Proliferating cell nuclear antigen)
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codrituzumab (RG7686)