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ateganosine

Phase 1

Resectable Hepatocellular Carcinoma | Small molecule | Oncology |MAIA Biotechnology, Inc.|Last Updated: Mar 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07446257THIO and Cadonilimab in Resectable Hepatocellular CarcinomaEARLY_PHASE1 NOT YET_RECRUITING 60May 1, 2026May 1, 2031Mar 3, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment-related delay of surgical resection >28 days from expected surgery date.
28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)

Safety is measured as the proportion of participants who experience a treatment-related delay in the planned surgical resection, defined as surgery occurring more than 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)

Secondary Endpoints
Pathologic response of ateganosine plus cadonilimab
Day 1 of treatment up to surgery resection
Radiographic response after ateganosine plus cadonilimab
Baseline to between day 2-4 of the last cycle immediately prior to surgery
Survival outcomes after ateganosine plus cadonilimab
first dose of drug (whichever was last) up to 36 months until death, loss to follow-up, or until study termination by the Sponsor.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: Ateganocine + CadonilimabEXPERIMENTALAteganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes
Arm B: AteganocineEXPERIMENTALAteganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes
Arm C: CadonilimabEXPERIMENTALCadonilimab: 10 mg/kg IV over 60 minutes±5 minutes
Interventions
NameTypeDescription
ateganosineDRUGateganosine: 180 mg IV D1, D2, D3 of 21-day cycle
CadonilimabDRUGcadonilimab: 10 mg/kg IV D5 of 21-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria a. Availability of tumor tissue samples prior to the first day of study treatment is required for all patients. 2. HCC that is amenable to R0 r...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07446257studyFirstPostDate: changed