PT-112 in Subjects With Thymoma and Thymic Carcinoma (NCT05104736) | Clinical Trial Compass
RecruitingPhase 2
PT-112 in Subjects With Thymoma and Thymic Carcinoma
United States53 participantsStarted 2022-04-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Participants must have histologically confirmed thymoma or thymic carcinoma.
* Participants should have received at least one prior line of platinum-based chemotherapy. For participants who have refused cytotoxic chemotherapy, a rationale for refusal to receive standard first-line therapy will be captured in the case report form and the medical record. Progressive disease must be documented prior to study entry and participants must have advanced, unresectable disease that is not amenable to surgical resection.
* Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
* Participants must be aged \>=18 years.
* ECOG performance status \<=1.
* Participants must have adequate organ and marrow function as defined below:
* absolute neutrophil count \>= 1,500/mm3 OR \>= 1.5 x 10(9)/L
* platelets \>=100,000/mm3 OR (Bullet) 100 x 10(9)/L
* hemoglobin \>= 9g/dL (may have been transfused, at least 7 days prior)
* total bilirubin \<= 1.5 x the upper limit of normal range (ULN)
* AST(SGOT)/ALT(SGPT) \<= 2.5 x ULN OR \<= 5 x ULN for participants with documented metastatic disease to the liver
* creatinine \<= 1.5x ULN OR:
* creatinine clearance \>= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab
* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
overall response rate (ORR)
Timeframe: assessed every 8 weeks while on treatment and then every 3 months after that for a maximum of 8 years from the start of study