RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing SX-682 for Head and Neck Cancer

Q: Is NCT07667400 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07667400?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07667400?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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.

Official registry: https://clinicaltrials.gov/study/NCT07667400 · National Cancer Institute (NCI) · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SX-682, or DTX. The registry lists allocation as randomized. Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide.

They plan to enroll about 120 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: SX-682, DTX

Primary outcome (registry wording): Phase I: To determine the RP2D of SX-682 in combination with DTX in participants with HNSCC, SGC, or mCRPC

Who it is for (from inclusion criteria)

Ages 18 Years to 120 Years
Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
Participants must have adequate organ and marrow function as defined below:
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

Who the registry excludes

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)
Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s)
Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or how well it works assessment of the study treatment
Participants with HNC
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

Public study contact (from the registry)

Michele L Reed, R.N.

(240) 760-6121

michele.reed@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07667400 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07667400?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07667400?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary