Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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
2 other identifiers
interventional
120
1 country
1
Brief Summary
Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed. Objective: To test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer. Eligibility People aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread. Design: Participants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken. Participants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles. Participants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 head-and-neck-cancer
Started Aug 2026
Longer than P75 for phase_1 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
August 5, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2036
Study Completion
Last participant's last visit for all outcomes
October 1, 2037
July 31, 2026
June 22, 2026
10.2 years
June 24, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: To determine the RP2D of SX-682 in combination with DTX in participants with HNSCC, SGC, or mCRPC
Toxicities will be tabulated and reported according to grade and type of toxicity experienced. Responses will be reported as the proportion of evaluable participants along with a confidence interval.
28 days
Phase II: To determine the efficacy of the combination of SX-682 and DTX in participants with HNSCC or SGC using ORR per RECIST v 1.1 or with mCRPC using RECIST v1.1 and Prostate Cancer Working Group 3
Overall response rate (ORR) as defined by the proportion of participants who achieve a response (CR+PR) will be reported separately for each, along with 95% and 80% confidence intervals (Clopper-Pearson).
Assessment at baseline, C4D8, 7 days after C6, and then every 3 months until PD or until 2 years after study treatment initiation
Secondary Outcomes (3)
To assess safety of SX-682 in combination with DTX
Assessed from the first study treatment, C1D1, through safety visit (28 days post-treatment) or start of new anticancer treatment, whichever comes first.
To assess progression free survival (PFS)
Assessed at C1D1, C4D8, 7 days after C6, and then every 3 months until PD or until 2 years after study treatment initiation.
To assess overall survival (OS)
Assessed at C1-6D1, at the 28-day Safety visit; every 3 months until disease progression or 2 years after start of study treatment; every 6 months after disease progression until 5 years after start of study treatment.
Study Arms (2)
Arm 1
EXPERIMENTALEscalating doses of SX-682 + DTX
Arm 2
EXPERIMENTALSX-682 at RP2D + DTX
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +22 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charalampos Floudas, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
June 25, 2026
Study Start (Estimated)
August 5, 2026
Primary Completion (Estimated)
October 1, 2036
Study Completion (Estimated)
October 1, 2037
Last Updated
July 31, 2026
Record last verified: 2026-06-22
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
- Access Criteria
- Clinical data will be made available upon request and with the permission of the study Pl. Genomic data are made available via dbGAP through requests to the data custodians.
This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.