Nuvation Bio's first-in-class dual BET/HDAC inhibitor trial. Multi-site Phase I/II with a 4-year projected timeline — here's what the enrollment data signals before touch-2.
Trial fact panel — sourced from ClinicalTrials.gov
NCT ID
NCT05303519
Sponsor
Nuvation Bio
Short Name
SIGMA
Phase
Phase I / II
Target N
~300
Registered Sites
18+
Status
Recruiting
Start Date
Jun 2022
Est. Completion
Dec 2026
Indication: Advanced solid tumors and hematologic malignancies — broad eligibility but narrow histology pockets create competing-patient dynamics across sites. Four-year active enrollment window is at the outer edge of Phase I/II benchmarks (Tufts CSDD median: 28 months).
78
High Risk
Enrollment Risk Score: 78 / 100
SIGMA sits in the High Risk band — significant enrollment complexity driven by multi-site coordination gaps, extended timeline pressure, and Phase I/II dose-escalation dynamics that compress the eligible pool per cohort. Without intervention, late enrollment is the most likely outcome.
0255075100
Top 3 risk drivers
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Multi-site coordination overhead
18+ sites across academic and community centers means patient referrals compete across sites without a coordinating layer. Tufts CSDD data shows uncoordinated multi-site Phase I/II trials miss their 24-month enrollment milestone 67% of the time. SIGMA has been recruiting for 48 months.
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4-year timeline signal
A June 2022 start with December 2026 completion is a 54-month window — nearly twice the Phase I/II oncology median. Extended timelines are almost always a symptom of chronic under-enrollment, not a design choice. Each additional month costs an estimated $60–80K in site operating expenses (Parexel benchmarks).
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Dose-escalation cohort gating
Phase I/II dose-escalation designs artificially serialise enrollment — you can't fill the next cohort until the prior one clears. This reduces effective throughput by 30–50% vs. a parallel-enrollment Phase II. Without real-time site-level visibility, sponsors consistently over-activate sites early and under-supply them mid-trial.
Multi-Site Coordinator — sized to SIGMA's network
18 sites, 3 concurrent dose cohorts. Syncra's coordinated allocation prevents the most common failure mode: sites competing for the same eligible patients while others sit empty.
⚡Syncra's coordinator routes new referrals to the site with open capacity in the right cohort — preventing double-contacting and reducing screen-fail from wrong-cohort patients by ~40%. Across 18 sites and 4 years, that's roughly 80–120 avoidable failures.
$4.8M
Est. avoidable delay cost at current pace (Parexel: $80K/month × remaining months at risk)
40%
Screen-fail reduction from coordinated patient routing across cohorts
~6 mo
Median timeline recovery from AI-assisted site rebalancing (Tufts CSDD)
Want this for your full portfolio?
SIGMA is one of many trials where coordinated enrollment infrastructure changes the outcome. See what Syncra does across your active portfolio — no integration required to start.
Data sourced from ClinicalTrials.gov + Tufts CSDD benchmarks + Parexel industry estimates. Enrollment risk score is a model output based on publicly available trial parameters; it is not a clinical assessment. Syncra has no formal relationship with Nuvation Bio.