Multiple clinical trials evaluate the therapeutic potential of XL888, primarily focusing on Phase 1 studies of monotherapy and combination regimens. These investigations target conditions such as advanced solid tumors, BRAF-mutated unresectable melanoma, and gastrointestinal malignancies including colorectal and pancreatic adenocarcinomas. Sponsored by academic research centers, industry partners, and the National Institutes of Health, the recruitment status across these protocols varies, encompassing completed, terminated, and active, not recruiting trials.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03095781 | COMPLETED | Colorectal Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Recurrent Colorectal Carcinoma; Recurrent Pancreatic Carcinoma; Stage III Colorectal Cancer; Stage III Pancreatic Cancer; Stage IIIA Colorectal Cancer; Stage IIIB Colorectal Cancer; Stage IV Colorectal Cancer; Stage IV Pancreatic Cancer; Stage IVA Colorectal Cancer; Stage IVA Pancreatic Cancer; Stage IVB Colorectal Cancer; Stage IVB Pancreatic Cancer; Unresectable Pancreatic Carcinoma |
Emory University |
2017-07-07 | PHASE1 |
| NCT02721459 | ACTIVE_NOT_RECRUITING | Melanoma; Skin Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2016-09-07 | PHASE1 |
| NCT03095781 | Completed | Colorectal Adenocarcinoma|Metastatic Pancreatic Adenocarcinoma|Recurrent Colorectal Carcinoma|Recurrent Pancreatic Carcinoma|Stage III Colorectal Cancer|Stage III Pancreatic Cancer|Stage IIIA Colorectal Cancer|Stage IIIB Colorectal Cancer|Stage IV Colorectal Cancer|Stage IV Pancreatic Cancer|Stage IVA Colorectal Cancer|Stage IVA Pancreatic Cancer|Stage IVB Colorectal Cancer|Stage IVB Pancreatic Cancer|Unresectable Pancreatic Carcinoma |
Emory University|Merck Sharp & Dohme LLC|Exelixis|National Institutes of Health (NIH)|National Cancer Institute (NCI) |
2017-07-07 | Phase 1 |
| NCT01657591 | COMPLETED | Melanoma |
H. Lee Moffitt Cancer Center and Research Institute |
2012-07-27 | PHASE1 |
| NCT00796484 | TERMINATED | Cancer |
Exelixis |
2008-11 | PHASE1 |
| NCT00796484 | Terminated | Cancer |
Exelixis |
2008-11 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-05-22)
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>).