Multiple clinical trials have evaluated BMS-777607 (also known as ASLAN002) in patients diagnosed with advanced and malignant solid tumors. Sponsored by pharmaceutical companies including Bristol-Myers Squibb and ASLAN Pharmaceuticals, these early-stage evaluations spanned Phase I and Phase I/II studies, including dose-escalation investigations. Currently, all recorded clinical trials assessing this compound have completed recruitment.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01721148 | COMPLETED | Malignant Solid Tumour |
ASLAN Pharmaceuticals |
2012-10 | PHASE1 |
| NCT01721148 | Completed | Malignant Solid Tumour |
ASLAN Pharmaceuticals |
2012-10 | Phase 1 |
| NCT00605618 | COMPLETED | Advanced Solid Tumors |
Bristol-Myers Squibb |
2008-03 | PHASE1; PHASE2 |
| NCT00605618 | Completed | Advanced Solid Tumors |
Bristol-Myers Squibb |
2008-03 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2017-01-25)
Check the
BMS-777607
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.