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DRUG:

muzastotug (ADG126)

i
Other names: ADG126, ADG-126
Associations
Company:
Adagene
Drug class:
CTLA4 inhibitor
Associations
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 | N=291 --> 542 | Trial completion date: Nov 2028 --> Jun 2028
Enrollment change • Trial completion date • First-in-human
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MSI (Microsatellite instability)
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HER-2 negative
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Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • SAR445877 • muzastotug (ADG126)
4ms
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
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Keytruda (pembrolizumab) • muzastotug (ADG126)
6ms
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
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Keytruda (pembrolizumab) • Avastin (bevacizumab) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil) • muzastotug (ADG126)
9ms
Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer (clinicaltrials.gov)
P2, N=20, Not yet recruiting, National University Hospital, Singapore
New P2 trial
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Keytruda (pembrolizumab) • muzastotug (ADG126)
12ms
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
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PD-L1 (Programmed death ligand 1)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • IO-108 • 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
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ADG106 • 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=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
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PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • NKT2152 • muzastotug (ADG126) • tobemstomig (RG6139)
almost2years
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
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Keytruda (pembrolizumab) • muzastotug (ADG126)
almost2years
Results of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody) in combo with pembrolizumab (Pembro) in patients (Pts) with metastatic microsatellite-stable (MSS) colorectal cancer (CRC). (ASCO-GI 2024)
ADG126/Pembro combination is well-tolerated up to the maximally administered dose of 10 mpk Q3W, with limited G3 TRAEs comparable to Pembro monotherapy. The 10 mpk ADG126 Q3W repeat dosing regimen maintains a favorable safety profile and demonstrates anti-tumor activity. The MSS CRC cohort of 10 mpk ADG126 Q3W surpassed the threshold set for part 1 of the Simon’s 2-stage design, and the second stage of the cohort is now enrolling.
Clinical • P1/2 data • Metastases
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Keytruda (pembrolizumab) • muzastotug (ADG126)
almost3years
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=320, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025
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) • muzastotug (ADG126) • tobemstomig (RG6139)