Docetaxel and SX-682 in head and neck cancers and prostate cancer
Official title: Phase I/II Trial of Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Run by National Institutes of Health Clinical Center (CC) · NCT07667400 · Data updated 2026-11-12
This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | denosumab, chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 15, 2026 |
| Main results expected | October 1, 2036 |
| Study ends | October 1, 2037 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07667400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with recurrent or metastatic head and neck cancers (including HNSCC, paranasal sinus neoplasms, nasopharyngeal or oropharyngeal carcinomas) or advanced prostate cancer, with adequate organ function and ECOG 0-2.
✕Probably not a fit
Patients with significant organ dysfunction, poor performance status, or disease not driven by CXCR1-2 pathways may not benefit, and standard therapies may be preferred.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early-phase interventional study enrolling adults with recurrent or metastatic head and neck cancers or prostate cancer. Participants receive SX-682 by mouth twice daily on days 1-11 of each 3-week cycle, alongside standard docetaxel treatment. The study includes screening with labs, imaging, and possibly a tumor biopsy to assess eligibility and baseline status. Primary goals are to determine safety and how the combination behaves in patients, with exploratory signals on anti-tumor activity. Conducted at the NIH Clinical Center under NCI sponsorship, the trial will monitor intolerability, organ function, and other treatment-related effects.
Why it matters
Potential benefit: If successful, participants may experience tumor control or slowed disease progression with a manageable safety profile from the combination therapy.
How similar studies have gone: Preclinical and early clinical data support CXCR1-2 blockade reducing immunosuppressive MDSCs and potentially enhancing docetaxel activity, suggesting potential benefit for this combination.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: All Participants * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2 * Participants must have adequate organ and marrow function as defined below: * ANC \>= 1,500/mcL * Hemoglobin (Hgb) \>= 9 g/dL * Platelets (PLTs) \>= 100,000/mcL * Creatinine clearance \>= 50 mL/min (by Cockroft-Gault formula) * Total bilirubin \<= 1.5 x iULN (\<= 3 x ULN in participants with known/suspected Gilbert s disease) * ALT/AST \<= 2.5 x iULN * Activated partial thromboplastin time (aPTT) \<= 1.5 x iULN * Contraception as follows: * Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement. * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period. * Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs. * Participants must be able to swallow oral medications. * Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation. * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL. * Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL. * Participants must be able to understand and willing to sign a written informed consent document. Participants with HNC * Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent/metastatic (R/M) or advanced incurable disease. * Prior treatment as follows: * Participants with R/M HNSCC must have prior systemic treatment (platinum-based chemotherapy and/or anti-PD(L)1 treatment). * Participants with R/M SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation. * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \<2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment. * Presence of \>= 1 measurable lesion by RECIST v 1.1 criteria. Participants with mCRPC * Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease. * Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1. * Participants must need ADT as part of their cancer therapy (unless previous orchiectomy) * Castrate testosterone level (\<50 ng/dl or 1.7 nmol/L) * Prior treatment as follows: * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide. * Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan. * Toxicities related to prior therapy, including surgery and/or radiation, must have resolved to \< Grade 1 per CTCAE v.6.0. EXCLUSION CRITERIA: All participants * History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80). * Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment * Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s). * Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and/or complications from the intervention prior to starting study treatment. * Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment. * Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment. * Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements. Participants with HNC * Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \<2 (except for radiation-induced xerostomia/dysgeusia) or be minimal and not constitute a safety risk. * Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test Participants with mCRPC * Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation. * Cancer related neuropathy at screening * Baseline QTcF \>= 470 ms
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Charalampos Floudas, M.D. — National Cancer Institute (NCI)
- Study coordinator: Michele L Reed, R.N.
- Email: michele.reed@nih.gov
- Phone: (240) 760-6121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.