Convexia

Clinical Execution Risk Assessment

Comprehensive operational risk analysis for clinical trials

This report summarizes Convexia's Execution Risk Agent analysis of CT7439, a dual CDK12/13 inhibitor and Cyclin-K molecular glue degrader for advanced solid tumors. Results are derived from integrated kinase binding models, oncology patient population analytics, dose-escalation safety projections, and a Phase I trial execution digital twin—computed in hours on high‑performance GPUs.

CT7439
Advanced solid tumors (breast cancer focus) • Phase I • Small Molecule
72
High Risk
Countries: 8
Sites: 25
Duration: 18 months
Budget: $45,000,000

Molecular Details

Gene Symbol: CDK12
UniProt ID: Q9NYV4
Structure Type: Small molecule
Mechanism: CDK12/13 inhibitor & Cyclin-K molecular glue degrader
Route: Oral

Trial Information

Study Design: Open-label, dose-escalation
Primary Endpoint: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Patient Population: Advanced solid tumors with breast cancer enrichment
Protocol Number: CT7439-001
ClinicalTrials.gov: NCT06600789

Selected CRO

Medpace Holdings Inc
Overall Execution Risk Assessment
Comprehensive analysis of operational factors affecting CT7439 Phase I trial success probability
68
Risk Score
Risk Component Analysis
Click each component to view detailed analysis, data sources, and recommendations
Biomarker Screening Complexity85/100

CDK12/13 expression analysis and Cyclin-K degradation assessment requiring fresh biopsies in 60% of patients

Dose-Escalation Timeline Risk72/100

3+3 design with 28-day DLT evaluation periods creating sequential enrollment constraints

Limited Site Network68/100

Specialized Phase I oncology sites required with biomarker testing and fresh biopsy capabilities

Manufacturing Scale-Up Risk58/100

Small molecule API production scaling from research to clinical quantities with purity challenges

Regulatory Pathway Uncertainty45/100

Phase I design acceptable but expansion strategy unclear without biomarker validation

Recommended Actions
Prioritized interventions to reduce execution risk and improve trial success probability
Establish Biomarker Pre-Screening ConsortiumCritical
Implement Adaptive Dose-Escalation DesignHigh