Multiple Phase 1 and Phase 1/2 clinical trials sponsored by Bristol-Myers Squibb have evaluated BMS-754807 as monotherapy and in combination with targeted biological agents to determine its safety, pharmacokinetics, and therapeutic efficacy. These completed and terminated studies investigated the compound across several populations, including healthy volunteers and patients with advanced or metastatic solid tumors, breast cancer, colorectal cancer, and head and neck cancer.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01225172 | TERMINATED | Breast Cancer |
Bristol-Myers Squibb |
2010-12-31 | PHASE2 |
| NCT00569036 | COMPLETED | Neoplasms; Solid Tumors; Metastases |
Bristol-Myers Squibb |
2008-04 | PHASE1 |
| NCT00908024 | TERMINATED | Colorectal Cancer; Head and Neck Cancer; Neoplasm Metastasis |
Bristol-Myers Squibb |
2009-10 | PHASE1; PHASE2 |
| NCT00793897 | COMPLETED | Advanced Solid Tumors; Metastatic Solid Tumors |
Bristol-Myers Squibb |
2009-04 | PHASE1 |
| NCT01525823 | COMPLETED | Healthy Volunteers |
Bristol-Myers Squibb |
2012-02 | PHASE1 |
| NCT01525823 | Completed | Healthy Volunteers |
Bristol-Myers Squibb |
2012-02 | Phase 1 |
| NCT00788333 | COMPLETED | Breast Cancer |
Bristol-Myers Squibb |
2009-07 | PHASE1; PHASE2 |
| NCT00898716 | COMPLETED | Neoplasms |
Bristol-Myers Squibb |
2009-09 | PHASE1 |
| NCT00908024 | Terminated | Colorectal Cancer|Head and Neck Cancer|Neoplasm Metastasis |
Bristol-Myers Squibb |
2009-10 | Phase 1|Phase 2 |
| NCT00898716 | Completed | Neoplasms |
Bristol-Myers Squibb |
2009-09 | Phase 1 |
| NCT00788333 | Completed | Breast Cancer |
Bristol-Myers Squibb |
2009-07 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2020-08-11)
Check the
BMS-754807
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.