MINTER Trial: Metal Intervention aNd ThErapy With Radiotherapy In Thoracic Cancer Using Copper Donor Therapy: A Phase 2, Open-Label Study
2 other identifiers
interventional
30
1 country
1
Brief Summary
This study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of cancer cell death knowns as "cuproptosis".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2027
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2030
Study Completion
Last participant's last visit for all outcomes
March 30, 2032
September 28, 2026
September 1, 2026
3.1 years
September 21, 2026
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Through study completion; an average of 1 year
Study Arms (1)
Treatment with Disulfiram + Copper Gluconate + Concurrent LCT
EXPERIMENTALInterventions
Given orally once daily
Given orally three times daily
Delivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy).
Eligibility Criteria
You may qualify if:
- Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation
- Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)
- Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)
- Age ≥18 years.
- ECOG 0-2.
- Adequate organ and marrow function within 28 days prior to enrollment defined as:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5 × ULN (≤3 × ULN for patients with known Gilbert's syndrome)
- AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with hepatic metastases)
- Ability to provide written informed consent.
- Prior thoracic radiation allowed as long as cumulative organ as risk constraints are met
You may not qualify if:
- Uncontrolled intercurrent illness.
- Known hypersensitivity to Disulfiram.
- Contraindications to radiation therapy.
- Inability to stay away from alcohol products during the use of Disulfiram.
- Wilson's Disease (copper overload disorder)
- Hepatic dysfunction with AST/ALT/bilirubin levels that are outside 2.5 X normal range (≤2.5 × ULN)
- Hypersensitivity to copper-containing compounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Lin, MD, PHD
UT MD Anderson
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2026
First Posted
September 28, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
March 30, 2030
Study Completion (Estimated)
March 30, 2032
Last Updated
September 28, 2026
Record last verified: 2026-09