CFI-400945 is currently undergoing evaluation in multiple Phase 1, Phase 2, and Phase 1/2 clinical trials as both monotherapy and combination regimens. These studies target hematologic malignancies—including acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia—as well as solid tumors such as breast, prostate, and advanced refractory cancers. Sponsored by industry entities like Treadwell Therapeutics and AstraZeneca alongside academic institutions such as the Canadian Cancer Trials Group and University Health Network Toronto, trial statuses range from completed early-phase safety studies to active, recruiting, and active-not-recruiting protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05601440 | RECRUITING | Breast Cancer |
Canadian Cancer Trials Group |
2023-06-13 | PHASE2 |
| NCT03624543 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Canadian Cancer Trials Group |
2019-02-14 | PHASE2 |
| NCT04730258 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; AML; MDS; CMML |
Treadwell Therapeutics, Inc |
2021-04-16 | PHASE1; PHASE2 |
| NCT03385655 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Canadian Cancer Trials Group |
2018-08-01 | PHASE2 |
| NCT04176848 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Canadian Cancer Trials Group |
2020-08-10 | PHASE2 |
| NCT01954316 | COMPLETED | Advanced Cancer |
University Health Network, Toronto |
2014-03 | PHASE1 |
| NCT03187288 | COMPLETED | Acute Myeloid Leukemia; Myelodysplastic Syndromes; Relapsed Cancer; Refractory Cancer |
University Health Network, Toronto |
2018-05-25 | PHASE1 |
| NCT04730258 | Recruiting | Acute Myeloid Leukemia|Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia|AML|MDS|CMML |
Treadwell Therapeutics Inc |
2021-04-16 | Phase 1|Phase 2 |
| NCT04176848 | Unknown status | Breast Cancer |
Canadian Cancer Trials Group|AstraZeneca|University Health Network Toronto |
2019-12-19 | Phase 2 |
| NCT03624543 | Active not recruiting | Breast Cancer |
Canadian Cancer Trials Group|Stand Up To Cancer Canada-Canadian Cancer Society Breast Cancer Dream Team |
2019-02-14 | Phase 2 |
| NCT03187288 | Active not recruiting | Acute Myeloid Leukemia|Myelodysplastic Syndromes|Relapsed Cancer|Refractory Cancer |
University Health Network Toronto |
2018-05-25 | Phase 1 |
| NCT01954316 | Completed | Advanced Cancer |
University Health Network Toronto|The Princess Margaret Cancer Foundation|California Institute for Regenerative Medicine (CIRM) |
2014-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-05-07)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).