XL092 is currently being evaluated in multiple clinical trials spanning Phase 1 through Phase 3 to investigate its safety, pharmacokinetics, and therapeutic efficacy across diverse malignancies, including renal cell carcinoma, radioiodine-refractory thyroid carcinoma, metastatic castration-resistant prostate cancer, colorectal cancer, and advanced solid tumors. Sponsored by Exelixis, academic institutions, and clinical investigators, these single-agent and combination studies range in recruitment status from recruiting and active not recruiting to terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06959641 | RECRUITING | Locally Advanced Differentiated Thyroid Gland Carcinoma; Locally Advanced Poorly Differentiated Thyroid Gland Carcinoma; Locally Advanced Thyroid Gland Follicular Carcinoma; Locally Advanced Thyroid Gland Oncocytic Carcinoma; Locally Advanced Thyroid Gland Papillary Carcinoma; Metastatic Differentiated Thyroid Gland Carcinoma; Metastatic Poorly Differentiated Thyroid Gland Carcinoma; Metastatic Thyroid Gland Follicular Carcinoma; Metastatic Thyroid Gland Oncocytic Carcinoma; Metastatic Thyroid Gland Papillary Carcinoma; Refractory Differentiated Thyroid Gland Carcinoma; Refractory Poorly Differentiated Thyroid Gland Carcinoma; Refractory Thyroid Gland Follicular Carcinoma; Refractory Thyroid Gland Oncocytic Carcinoma; Refractory Thyroid Gland Papillary Carcinoma; Stage III Differentiated Thyroid Gland Carcinoma AJCC v8; Stage III Thyroid Gland Follicular Carcinoma AJCC v8; Stage III Thyroid Gland Papillary Carcinoma AJCC v8; Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8; Stage IV Thyroid Gland Follicular Carcinoma AJCC v8; Stage IV Thyroid Gland Papillary Carcinoma AJCC v8 |
Jochen Lorch |
2025-06-06 | PHASE2 |
| NCT06082167 | ACTIVE_NOT_RECRUITING | Head and Neck Squamous Cell Carcinoma |
Exelixis |
2024-06-07 | PHASE2; PHASE3 |
| NCT07773454 | NOT_YET_RECRUITING | Cancer; Pediatric Cancer |
Exelixis |
2026-09-30 | PHASE1 |
| NCT06571734 | RECRUITING | Metastatic Leiomyosarcoma; Unresectable Leiomyosarcoma; Bone Sarcoma; Translocation-associated Soft Tissue Sarcoma; Synovial Sarcomas; Osteosarcoma Metastatic; Ewing Sarcoma; Ewing Sarcoma Metastatic; Sarcoma Metastatic; Sarcoma of Bone |
Northwestern University |
2024-09-19 | PHASE2 |
| NCT07578025 | NOT_YET_RECRUITING | Metastatic Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8 |
City of Hope Medical Center |
2026-11-28 | PHASE2 |
| NCT06794229 | RECRUITING | Locally Advanced Renal Cell Carcinoma |
Qian Qin |
2025-10-30 | PHASE2 |
| NCT07484139 | NOT_YET_RECRUITING | Oral Cavity Squamous Cell Carcinoma; Head and Neck Cancer |
UNC Lineberger Comprehensive Cancer Center |
2026-09 | PHASE2 |
| NCT06902376 | RECRUITING | Anaplastic Thyroid Cancer; Thyroid Cancer; BRAF Mutation-Related Tumors |
UNC Lineberger Comprehensive Cancer Center |
2025-06-03 | PHASE1 |
| NCT06863311 | RECRUITING | Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma |
Karie Runcie |
2026-03-13 | PHASE2 |
| NCT05176483 | RECRUITING | Renal Cell Carcinoma (RCC); Metastatic Castration-Resistant Prostate Cancer (mCRPC); Urothelial Carcinoma (UC); Solid Tumor; Hepatocellular Carcinoma (HCC); Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Head and Neck Squamous Cell Carcinoma (HNSCC); Clear Cell Renal Cell Carcinoma (ccRCC); Non-Clear Cell Renal Cell Carcinoma (nccRCC); Drug-Drug Interaction (DDI) |
Exelixis |
2021-12-14 | PHASE1 |
| NCT06698250 | RECRUITING | Hepatocellular Carcinoma |
Anwaar Saeed |
2024-12-18 | PHASE2 |
| NCT05678673 | ACTIVE_NOT_RECRUITING | Non-Clear Cell Renal Cell Carcinoma |
Exelixis |
2023-01-01 | PHASE3 |
| NCT06568562 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
University of Utah |
2024-12-09 | PHASE2 |
| NCT03845166 | ACTIVE_NOT_RECRUITING | Neoplasm Malignant; Renal Cell Carcinoma; Hormone Receptor Positive Breast Carcinoma; Metastatic Castration-resistant Prostate Cancer; Colorectal Cancer |
Exelixis |
2019-03-20 | PHASE1 |
| NCT05425940 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Exelixis |
2022-09-07 | PHASE3 |
| NCT03337698 | TERMINATED | Carcinoma, Non-Small-Cell Lung |
Hoffmann-La Roche |
2017-12-27 | PHASE1; PHASE2 |
| NCT06191796 | TERMINATED | Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors |
Exelixis |
2024-01-25 | PHASE1 |
| NCT03845166 | Active not recruiting | Neoplasm Malignant|Renal Cell Carcinoma|Hormone Receptor Positive Breast Carcinoma|Metastatic Castration-resistant Prostate Cancer|Colorectal Cancer |
Exelixis |
2019-03-20 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-06-26)
Check the
XL092
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.