^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    muzastotug (ADG126)

    i
    Other names: ADG126, ADG-126
    Associations

    News

    Trials
    Company:
    Adagene
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    Associations

    News

    Trials
    13d
    Molecular complete response to the RIN protocol (regorafenib, ipilimumab, and nivolumab) in a patient with advanced recurrent metastatic mismatch repair proficient/microsatellite stable (pMMR/MSS) rectal cancer. (PubMed, Ther Adv Med Oncol)
    Rectal cancer recurrence remains a major therapeutic challenge, particularly in patients unresponsive to conventional regimens. While previous studies have demonstrated limited benefit of immunotherapy in this tumor subtype, the present findings suggest an emerging therapeutic opportunity that warrants prospective evaluation to confirm efficacy, explore the mechanistic basis, and identify biomarkers predictive of durable response beyond the absence of liver metastases. More effective combinatorial regimens like zanzalintinib and atezolizumb (STELLAR-303) trial, as well as newer generation of CTLA-4 inhibitors like botensilimab, vilastobart, and muzastotug are showing more promise for patients with MSS colorectal cancers in particular who do not have liver metastases (NLM).
    Journal • Mismatch repair • PD(L)-1 Biomarker • IO biomarker • pMMR
    |
    KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Stivarga (regorafenib) • botensilimab (AGEN1181) • vilastobart (XTX101) • muzastotug (ADG126) • zanzalintinib (XL092)
    1m
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=542, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF mutation • HER-2 negative • RAS mutation
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • SAR445877 • muzastotug (ADG126)
    2ms
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=518, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • IO-108 • imdatifan (NKT2152) • muzastotug (ADG126) • tobemstomig (RG6139)
    2ms
    Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    CD4 (CD4 Molecule)
    |
    irinotecan • leucovorin calcium • Yidafan (ivonescimab) • fluorouracil topical • muzastotug (ADG126)
    5ms
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=542, Recruiting, Sanofi | N=291 --> 542 | Trial completion date: Nov 2028 --> Jun 2028
    Enrollment change • Trial completion date • First-in-human
    |
    MSI (Microsatellite instability)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • SAR445877 • muzastotug (ADG126)
    9ms
    Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, National University Hospital, Singapore | Not yet recruiting --> Recruiting | Trial completion date: Oct 2027 --> Dec 2027 | Trial primary completion date: May 2027 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • muzastotug (ADG126)
    10ms
    KEYNOTE-C98: ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=152, Recruiting, Adagene Inc | Trial completion date: Sep 2025 --> Apr 2027 | Trial primary completion date: Mar 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil) • muzastotug (ADG126)
    1year
    Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, National University Hospital, Singapore
    New P2 trial
    |
    Keytruda (pembrolizumab) • muzastotug (ADG126)
    over1year
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=518, Recruiting, Hoffmann-La Roche | Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • IO-108 • imdatifan (NKT2152) • muzastotug (ADG126) • tobemstomig (RG6139)
    over1year
    ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=58, Completed, Adagene Inc | Recruiting --> Completed | N=91 --> 58 | Trial completion date: Dec 2024 --> May 2024
    Trial completion • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    ADG106 • muzastotug (ADG126)
    almost2years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=506, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2025 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • imdatifan (NKT2152) • muzastotug (ADG126) • tobemstomig (RG6139)
    2years
    KEYNOTE-C98: ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=131, Recruiting, Adagene Inc | Phase classification: P1b/2 --> P1/2 | N=72 --> 131
    Phase classification • Enrollment change
    |
    Keytruda (pembrolizumab) • muzastotug (ADG126)