Clinical Trials

SX-682 is currently being evaluated in several Phase 1 and Phase 2 clinical trials, supported by industry sponsors such as Syntrix Biosystems alongside academic institutions including the National Cancer Institute and university medical centers. These studies assess the small molecule as a monotherapy or combination therapy across diverse conditions, including myelodysplastic syndromes, non-small cell lung cancer, metastatic melanoma, pancreatic ductal adenocarcinoma, and prostate cancer. Encompassing recruitment statuses ranging from active recruiting to not yet recruiting, research efforts remain focused on evaluating safety, tolerability, and therapeutic efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07667400 NOT_YET_RECRUITING
Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Paranasal Sinus Neoplasms; Nasopharyngeal Carcinoma; Oropharyngeal Squamous Cell Carcinoma; Hypopharyngeal Cancer; Carcinoma of Larynx; Oral Squamous Cell Carcinoma; Salivary Gland Cancer; Adenoid Cystic Carcinoma; Prostate Cancer; Metastatic Castration Resistant Prostate Cancer
National Cancer Institute (NCI)
 2026-09-09 PHASE1; PHASE2
NCT07322341 RECRUITING
Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
University of Washington
 2026-10-01 PHASE2
NCT07002320 RECRUITING
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Institute of Cancer Research, United Kingdom
 2025-04-28 PHASE1; PHASE2
NCT04245397 RECRUITING
Myelodysplastic Syndromes
Syntrix Biosystems, Inc.
 2020-06-30 PHASE1
NCT06149481 RECRUITING
Metastatic Colorectal Cancer
National Cancer Institute (NCI)
 2024-03-26 PHASE1; PHASE2
NCT05570825 RECRUITING
Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
University of Washington
 2023-04-06 PHASE2
NCT06228053 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Syntrix Biosystems, Inc.
 2024-11-18 PHASE2
NCT06622005 RECRUITING
Recurrent Multiple Myeloma; Refractory Multiple Myeloma
Roswell Park Cancer Institute
 2025-04-10 PHASE1
NCT05604560 ACTIVE_NOT_RECRUITING
Pancreatic Cancer
Lei Zheng
 2023-11-08 PHASE2
NCT03161431 ACTIVE_NOT_RECRUITING
Melanoma Stage III; Melanoma Stage IV
Syntrix Biosystems, Inc.
 2019-06-12 PHASE1
NCT04599140 ACTIVE_NOT_RECRUITING
Metastatic Colon Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Rectal Adenocarcinoma
M.D. Anderson Cancer Center
 2020-10-14 PHASE1; PHASE2
NCT04477343 ACTIVE_NOT_RECRUITING
Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer
University of Rochester
 2020-11-23 PHASE1
NCT04574583 COMPLETED
Metastatic Cancer; Solid Tumors
National Cancer Institute (NCI)
 2020-11-24 PHASE1; PHASE2
NCT04245397 Recruiting
Myelodysplastic Syndromes
Syntrix Biosystems Inc.|H. Lee Moffitt Cancer Center and Research Institute|National Heart Lung and Blood Institute (NHLBI)|Johns Hopkins University|AdventHealth|Emory University|University of Miami|Mayo Clinic
 2020-05-12 Phase 1
NCT03161431 Recruiting
Melanoma Stage III|Melanoma Stage IV
Syntrix Biosystems Inc.|Massachusetts General Hospital|National Cancer Institute (NCI)|Dana-Farber Cancer Institute|Mayo Clinic|University of Rochester|M.D. Anderson Cancer Center|University of Miami
 2019-06-12 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the SX-682 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SX-682 acts as an orally bioavailable, selective allosteric inhibitor of the CXCR1 and CXCR2 chemokine receptors, blocking ligand-induced receptor activation and downstream signaling to impair the trafficking and infiltration of myeloid-derived suppressor cells into the tumor microenvironment. By reversing myeloid cell-mediated immunosuppression and promoting cytotoxic T-cell activation, this targeted disruption restores antitumor immune responses, supporting its clinical evaluation in solid tumors and hematologic malignancies such as non-small cell lung cancer, melanoma, and myelodysplastic syndromes.

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>).

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Note: Technical data last updated: Sep 1, 2026.