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    2ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Recruiting, Weill Medical College of Cornell University | Not yet recruiting --> Recruiting
    Enrollment open
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    CD8 (cluster of differentiation 8)
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    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    2ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Weill Medical College of Cornell University
    New P2 trial
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    CD8 (cluster of differentiation 8)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    3ms
    AGEN1423 Plus Balstilimab With or Without Chemo in Pancreatic Cancer (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Bruno Bockorny | Trial completion date: May 2025 --> May 2027 | Trial primary completion date: May 2024 --> May 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • dalutrafusp alfa (AGEN1423)
    6ms
    Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Terminated, Gilead Sciences | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
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    5-fluorouracil • oxaliplatin • leucovorin calcium • dalutrafusp alfa (AGEN1423)
    over1year
    Phase 1 first-in-human study of dalutrafusp alfa, an anti-CD73-TGF-β-trap bifunctional antibody, in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    Dalutrafusp alfa doses up to 45 mg/kg Q2W were well tolerated in patients with advanced solid tumors. Additional evaluation of dalutrafusp alfa could further elucidate the clinical utility of targeting CD73-adenosine and TGF-β pathways in oncology.
    P1 data • Journal • Metastases
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    CD8 (cluster of differentiation 8) • TGFB1 (Transforming Growth Factor Beta 1)
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    dalutrafusp alfa (AGEN1423)
    over1year
    Phase 2 trial of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination with Balstilimab, with or without Chemotherapy in Subjects with Advanced Pancreatic Cancer (SITC 2022)
    In cohort 2, twelve patients with metastatic PDAC following disease progression on fluorouracil-based therapy will be enrolled to receive AGEN1423 30mg/kg plus balstilimab 3mg/kg on days 1 and 15 of a 28-day cycle in combination with gemcitabine 1000 mg/m2 plus nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 of a 28-day cycle. Biopsies will be obtained at baseline and on-treatment for multiplex immunohistochemistry and additional genomic analyses to better understand changes in the tumor microenvironment following AGEN1423 and balstilimab treatment. Recruitment is anticipated to commence in Q3 2022.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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    NT5E (5'-Nucleotidase Ecto) • TGFB1 (Transforming Growth Factor Beta 1)
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    CD73 expression
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    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • balstilimab (AGEN2034) • dalutrafusp alfa (AGEN1423)
    over2years
    Characterization of peripheral biomarkers of GS-1423, a first in class bifunctional anti-CD73-TGFβ receptor II- trap molecule, in a Phase 1 dose escalation study in patients with advanced solid tumors (SITC 2021)
    Conclusions Blood biomarker analyses of GS-1423 in patients with advanced solid tumors demonstrated undetectable soluble TGFβ1/2/3 and complete TO of CD73 on B and T cells at the 20 mg/kg dose level and above. The mechanism underlying the increase in sCD73 following GS-1423 treatment remains to be elucidated.
    Clinical • P1 data
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    CD8 (cluster of differentiation 8) • TGFB1 (Transforming Growth Factor Beta 1)
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    dalutrafusp alfa (AGEN1423)