Acme Therapeutics · ONC-002
Relapsed/refractory multiple myeloma
Single-arm dose-expansion of acemyebrelin in r/r multiple myeloma. Enrolment is tracking 12% behind plan due to slow activation at two EU sites; mitigation underway with two new US sites in start-up.
Sit-rep
Status
Enrolling
Health
Watch
Forecast end
Jun 12, 2027
+28d vs plan
Projected EAC
18.4M USD
+600k USD vs contract
Live activity
No activity yetKey performance indicators
Threshold colour is supplementary to the on-target / at-risk / breached label.
- Enrolment
- 88 / 120 (73%)
- Screen failure rate
- 34%
- Query aging (>14d)
- 47 open
- Protocol deviations
- 23
- Projected DBL variance
- +28 days
- Budget burn
- 68%
- Forecast EAC
- $18.4M
Timeline & milestones
Bar shows planned span; tick marks current forecast end. Markers are colour-coded by milestone status (labels in tooltip / table below).
| Milestone | Planned | Actual / forecast | Variance | Status |
|---|---|---|---|---|
| FPI | Sep 15, 2024 | Oct 2, 2024 | +17d | Complete |
| 25% enrolment | Feb 15, 2025 | Mar 10, 2025 | +23d | Complete |
| 50% enrolment | Jun 30, 2025 | Jul 22, 2025 | +22d | Complete |
| 75% enrolment | Nov 30, 2025 | Jan 15, 2026 | +46d | In progress |
| LPI | Apr 15, 2026 | May 30, 2026 | +45d | At risk |
| LPLV | Oct 15, 2026 | Nov 30, 2026 | +46d | Planned |
| Database lock | Jan 15, 2027 | Feb 12, 2027 | +28d | Planned |
| CSR draft | Mar 15, 2027 | Apr 12, 2027 | +28d | Planned |
| CSR final | May 15, 2027 | Jun 12, 2027 | +28d | Planned |
| Severity | Title | Owner | Mitigation | Status |
|---|---|---|---|---|
| High | EU site activation delayed by competent authority backlog | Regulatory Lead | Escalated; two replacement US sites in qualification (target activation +45d). | Mitigating |
| Medium | Higher than expected screen failure on creatinine clearance criterion | Medical Monitor | Protocol amendment v3 in draft to relax CrCl from 60 to 50 mL/min. | Open |
| Medium | CRO sub-contracting central lab going through M&A | CRA Manager | Continuity letter on file; back-up lab identified. | Mitigating |
| Low | Investigator turnover at top-3 enrolling site | CRA Manager | Sub-investigator certified and trained. | Closed |
Resources
| Role | Headcount | FTE | Monthly rate | Monthly cost |
|---|---|---|---|---|
| CRA | 6 | 4.5 | 19k USD | 83k USD |
| Data Management | 3 | 2.4 | 15k USD | 36k USD |
| Pharmacovigilance | 2 | 1.0 | 18k USD | 18k USD |
| Biostatistics | 2 | 1.2 | 22k USD | 26k USD |
| Medical Writing | 1 | 0.5 | 20k USD | 10k USD |
| Total | 14 | 9.6 | — | 174k USD |
Financials
Contracted budget
17.8M USD
EBV spent
12.1M USD
68% of contract
EAC (estimate at completion)
18.4M USD
+600k USD vs contract
Burn vs time elapsed
68% / 64%
broadly aligned
Recent activity
Provenance events (24h)
412
Staging items pending
7
Signatures (7d)
24
View provenance for this study →View staged records for this study →
Study goals
Confirm ORR ≥ 35% per IMWG in the 600 mg cohort
Maintain ≤ 10% Grade 3+ neutropenia at the expansion dose
Lock database within 90 days of LPLV
Deliver CSR within 120 days of database lock