Actively Recruiting
PT-112 in Subjects With Thymoma and Thymic Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-12
53
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers. Researchers want to see if the drug PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight cancer. Objective: To see if the study drug PT-112 can cause tumors to shrink. Eligibility: People ages 18 and older who have thymoma or thymic cancer and whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy, or who have refused standard treatment. Design: Participants will be screened with: Review of medical history and medications Physical exam Blood and urine tests CT or MRI scans of parts of the body, including the brain Participants will get PT-112 in 28-day cycles, on days 1 and 15 of of the first cycle and on day 1 of each cycle after that. They will get the drug by infusion through a catheter. The catheter is a small plastic tube put into a vein. On days they receive the drug, participants will have physical exams and blood and urine tests. They will have an ECG to test heart function on day 1 of each cycle. Participants will have scans every 8 weeks. Participants may choose to have tumor biopsies on day 1 of cycles 1 and 3. Biopsies may be guided by an ultrasound or CT scan. Participants will continue treatment as long as they can handle the side effects and their disease does not get worse, for up to 8 years. Participants will have follow-up visits 2 weeks and 4 weeks after they stop therapy. Then the study team will check on participants every 3 months until 8 years after the participant joined the study.
CONDITIONS
Official Title
PT-112 in Subjects With Thymoma and Thymic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed thymoma or thymic carcinoma.
- Participants should have received at least one prior line of platinum-based chemotherapy or have refused cytotoxic chemotherapy with documented rationale.
- Progressive disease must be documented before study entry with advanced, unresectable disease not suitable for surgery.
- Disease must be measurable with at least one unidimensional lesion by RECIST 1.1.
- Participants must be aged 18 years or older.
- ECOG performance status must be 0 or 1.
- Adequate organ and marrow function, including neutrophil count ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 times upper limit of normal, liver enzymes ≤ 2.5 times upper limit (or ≤ 5 times if liver metastases), creatinine ≤ 1.5 times upper limit or creatinine clearance ≥ 60 mL/min/1.73 m2.
- Negative pregnancy test for individuals of childbearing potential.
- Use of effective contraception during the study and for 6 months after last dose for those of childbearing potential.
- Previously treated brain or CNS metastases allowed if recovered and no steroid treatment needed, with whole brain radiation completed at least 2 weeks prior.
- Ability to understand and sign informed consent.
You will not qualify if you...
- History of allergic reactions to compounds similar to PT-112.
- Use of non-permitted drugs or concurrent anticancer treatment within 14 days before starting study therapy (except palliative bone radiotherapy).
- Major surgery within 14 days before enrollment (excluding diagnostic biopsy).
- Systemic immunosuppressive therapy within 14 days before study therapy.
- Use of hormonal agents for cancer therapy or investigational drugs within 14 days before study therapy.
- History of other malignant disease within last 2 years, except specified non-invasive cancers.
- Active infections requiring systemic therapy or significant infections including hepatitis B or C, or HIV with detectable viral load.
- Persistent toxicity from prior therapy greater than Grade 1, except alopecia, sensory neuropathy Grade ≤ 2, or hearing loss Grade ≤ 2.
- Known alcohol or drug abuse.
- Uncontrolled illness including symptomatic heart failure, unstable angina, recent arrhythmia, active lung fibrosis or pneumonitis, active immune colitis or inflammatory bowel disease, major bleeding events, or psychiatric illness limiting study compliance.
- Live vaccines administered within 4 weeks prior to treatment (COVID-19 vaccines allowed).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Shannon G Swift, R.N.
CONTACT
A
Arun Rajan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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