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VG2025

Phase 1

Colorectal Cancer With Hepatic Metastases | Monoclonal antibody | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 21, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07357220A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver MetastasesPHASE1 NOT YET_RECRUITING 72Mar 2, 2026Feb 28, 2028Jan 21, 20261 China
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Study Endpoints
Primary Endpoints
Number of participants experiencing dose-limiting toxicities (DLTs)
From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts

Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period

Number of participants with adverse events (AEs) and severity
From ICF up to 30 days after last study treatment

Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0

Objective Response Rate (ORR)
Time Frame: Up to 2 years

Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1

Secondary Endpoints
Progression free survival (PFS)
Up to 2 years
Disease control rate (DCR)
Up to 2 years
Duration of response (DoR)
Up to 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A (VG2025+AK112)EXPERIMENTALVG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W + AK112 (20mg/kg), ivgtt, Q2W.
Cohort B (AK112)EXPERIMENTALAK112 (20mg/kg), ivgtt, Q2W
Interventions
NameTypeDescription
VG2025BIOLOGICALRecommended Phase II Dose, Intratumoral Injection, Q4W
AK112DRUG20mg/kg, ivgtt, Q2W
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed informed consent 2. Age≥18 years and ≤ 75 years 3. Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type 4. Disease progression after first- or second-line standard therapy 5. At least one measurable disease...

Countries:China
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