None listed
Conditions
Interventions
Drug, Medical Device, Radiation : [IP]
- Title: DMX-101
- Dose: 500~750mg/kg
- Administration: single dose
- Route: IV
[ID]
- Title: DM-BNCT, DM-BTPS(Radiation treatment planning software)
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 19 years of age or older (at the date of written informed consent) 2. Subjects who have at least one measurable lesion by RECIST (v1.1) criteria 3. Subjects with histologically confirmed locally or regionally recurrent squamous cell or non-squamous cell head and neck cancer with primary site of disease identified as the nasopharynx, oral cavity or oropharynx, hypopharynx, lips, larynx, salivary glands, nasal cavity, and paranasal sinuses. 4. Subjects whose tumor location is confirmed as follows 4-1) The tumor center is located between the arresting surface and the mucosa, and the tumor is located within 7 cm of the body surface 4-2) Target lesion is located within 12 cm in diameter 5. Subjectss who have been previously irradiated with 75 Gy or less when applying radiotherapy alone or concurrent chemoradiotherapy in the following ways 5-1) Radical radiation alone or radiochemotherapy (Definitive RT/CRT) 5-2) Postoperative radiation alone or radiochemotherapy (Surgery + PORT/CRT) Those who are refractory to conventional standard therapy or have disease progression, or for whom there is no currently available standard therapy due to intolerance/inappropriateness, poor prognosis, or refusal of standard therapy. 5-3) Induction chemotherapy and radiation alone or radiochemotherapy (Induction CTx+Definitive RT/CRT) 5-4) Induction chemotherapy and postoperative radiation alone or radiochemotherapy (Induction CTx+Surgery+PORT/CRT) 5-5) Preoperative radiation alone or radiochemotherapy followed by surgery (Preoperative RT/CRT+Surgery) 5-6) Radiation therapy with Cetuximab (Cetuximab+RT) 6. Subjects who are defined as follows for currently applicable therapies 6-1) (For Phase I clinical trials) Patients who are refractory to existing standard therapy or have disease progression, or for whom there is no currently available standard therapy due to intolerance/inappropriateness, poor prognosis, or refusal of standard therapy. 6-2) (For Phase II clinical trials) Patients who are inoperable, ineligible for re-radiation therapy, and ineligible PD-1/PD-L1/EGFR inhibitors. *Inoperable: defined as unresectable, medically inoperable, or patient refusal of surgery. *Ineligible for re-radation theraspy: defined as unresectable, inoperable (medically inoperable), or the patient refuses to undergo surgery. *Ineligible for PD-1/PD-L1/EGFR inhibitor: defined as ineligible or refused by the patient due to concerns about serious adverse events, and no history of treatment after relapse. 7. ECOG =2 8. Subjects with adequate hematologic, renal, and hepatic function as determined by the following (one retest of laboratory tests is allowed during screening) - ANC =1,500/mm3 - Platelet count =100,000/mm3 - Hemoglobin =9 g/dL - Serum Cr or CrCL (Cockcroft-gault equation)=1.5 x ULN (=60 mL/min) - Total bilirubin=1.5 x ULN (=3.0 x ULN for Gilbert's syndrome) - AST and ALT=3 x ULN - PT (INR) and aPTT =1.5 × ULN (if on anticoagulation, unless within therapeutic range for the intended use of anticoagulation) 9. Subjects who are expected to survive at least 90 days after BNCT. 10. Subjects who can lie down or sit in the treatment position confirmed at BNCT simulation prescription or set-up visit for 30 minutes to 1 hour. 11. Subjects who are able to provide tissue samples 12. Subjects with no metal implants such as cardiac pacemakers, etc. 13. Subjects who voluntarily decide to participate and give written informed
Exclusion criteria
Exclusion criteria: 1. Subjects who have any of the following comorbidities; 1-1) Uncontrolled diabetes mellitus 1-2) Severe or greater chronic obstructive pulmonary disease according to chronic obstructive pulmonary disease guidelines or Grade II or greater dyspnea according to American thoracic society dyspnea scale 1-3) Class III or greater cardiac disease according to the NYHAFC 1-4) Grade 3 or greater (CTCAE V5.0) at the site of the target lesion scheduled for radiation irradiation 1-5) In need of urgent dental or gum treatment as determined by the investigator 2. Subjects with the following medical history 2-1) Myocardial infarction, unstable angina or uncontrolled arrhythmia within 24 weeks of the date of BNCT 2-2) Phenylketonuria 2-3) Hypovolemic dehydration and hereditary fructose intolerance 2-4) Previously diagnosed cancer of any other site at the time of the screening visit, with a disease-free period not exceeding 2 years (except for patients with skin basal cell carcinoma and cervical intraepithelial neoplasia who have received radical treatment) 3. Subjects who have received the following drug/non-drug therapies 3-1) Other anticancer therapy within 4 weeks prior to the date of BNCT 3-2) Major surgery for head and neck cancer within 4 weeks of screening visit and minor surgery within 1 week of screening visit 3-3) Radiation therapy to the target lesion within 24 weeks of the date of BNCT 3-4) History of previous BNCT 3-5) Use of other investigational drugs and medical devices within 4 weeks of the date of BNCT 4. Subjects who have metastatic lesions from the primary cancer site that have not been removed. Except that subjects may be eligible to participate in the study after review and approval by an ad hoc safety review committee and/or independent data monitoring committee in following conditions; 4-1) (For Phase I clinical trials) Subjects who have received radical treatment (such as SBRT) for the metastatic site up to 4 weeks prior to the date of BNCT, or observed metastasis of tumors with indolent growth, such as adenoid cystic carcinoma. 4-2) (For Phase II) Subjects who have received radical treatment (SBRT, etc.) for the metastatic site up to 4 weeks prior to the date of BNCT. 5. Subjects with tumor which is in contacting with the skin (including mucous membranes) and surrounds more than 1/3 of the carotid artery (120 degrees), or completly surrounds the carotid artery. 6. Subjects who are pregnant or breastfeeding. 7. Women or men of childbearing potential who are planning to become pregnant or unwilling to use adequate contraception from the date of written informed consent until 24 weeks after administration of the investigational product 8. Subjects unable to undergo the imaging studies required for this study 9. Subjects with hypersensitivity or history of hypersensitivity to boron and any component of the investigational drug product. 10. Subjects with difficulty or unsuitability to perform CT-simulation or BNCT procedures. 11. Subjects with any other reason that makes participation in this study unsuitable or impossible in the judgment of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (For Phase 1 clinical trial) Dose limiting toxicity;(For Phase 2 trial) Object response rate within 24 weeks evaluted by central imaging based on RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of LAT-1 transporter expression and distribution with ORR, Local PFS, and OS outcomes | — |
Countries
Korea, Republic of
Contacts
Public ContactYooseo Oh
National Cancer Center
Outcome results
None listed