Clinical Trials

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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-754807 acts as a potent, reversible inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) and insulin receptor (InsR), blocking receptor autophosphorylation and suppressing downstream signaling through Akt and MAPK pathways. Consequently, this molecular blockade inhibits cellular proliferation and induces tumor regression, providing the rationale for its clinical investigation in subjects with advanced solid tumors, breast cancer, and colorectal cancer.

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.