PT-112 in Subjects With Thymoma and Thymic Carcinoma
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|ClinicalTrials.gov Identifier: NCT05104736|
Recruitment Status : Recruiting
First Posted : November 3, 2021
Last Update Posted : January 20, 2023
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.
To see if the study drug PT-112 can cause tumors to shrink.
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.
Participants will be screened with:
Review of medical history and medications
Blood and urine tests
CT or MRI scans of parts of the body, including the brain
Participants will get PT-112 on days 1, 8, and 15 of 28-day cycles. 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.
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 for the rest of their life.
|Condition or disease||Intervention/treatment||Phase|
|Thymic Epithelial Tumor Recurrent Thymoma Thymic Cancer||Drug: PT-112||Phase 2|
Platinum-based chemotherapy is the standard of care for advanced unresectable thymic epithelial tumors (TETs). However, more than half of these patients experience disease recurrence and require second-line therapy.
There are no approved drugs for treatment of recurrent thymoma and thymic carcinoma and new therapeutic options are needed for patients who have disease progression on or after platinum-containing therapy.
PT-112, a first-in-class metallo-pyrophosphate conjugate, offers a unique set of properties of both cellular interaction and molecular antitumor mechanisms, including resistance to DNA repair pathways and induction of immunogenic cell death.
PT-112 has been clinically proven to be safe and tolerable and has demonstrated efficacy.
To determine the objective response rate (ORR) based on RECIST criteria v1.1 to PT-112 in patients with relapsed or refractory TETs.
Participants >= age 18 years with histologically confirmed, unresectable thymoma or thymic carcinoma who have previously been treated with at least one platinum-containing chemotherapy regimen or must have refused cytotoxic chemotherapy.
Participants must have progressive and measurable disease
Adequate renal, hepatic and hematopoietic function
This will be a single-arm, open-label study with two cohorts (cohort 1: thymoma; cohort 2: thymic carcinoma) to determine the clinical activity and safety of PT-112 in participants with relapsed or refractory TETs.
PT-112 will be administered intravenously on Days 1, 8 and 15 of a 28-day cycle at a dose of 360 mg/m2 until disease progression or development of intolerable adverse events.
For participants who develop intolerable toxicity at a dose of 360 mg/m2, two dose reductions will be permitted to 300 mg/m2 or 250 mg/m2 after resolution of adverse events to < grade 1 or baseline.
Toxicity will be assessed every cycle by CTCAE, version 5.0.
Tumor response will be assessed after completion of every other cycle (8 weeks) using RECIST criteria, version 1.1. Additionally, for participants with pleural dissemination tumor response will be assessed using International Thymic Malignancy Interest Group (ITMIG) modified RECIST criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label Trial of PT-112 in Subjects With Thymoma and Thymic Carcinoma|
|Actual Study Start Date :||April 6, 2022|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
PT-112 will be administered intravenously on Days 1, 8 and 15 of a 28-day cycle at a dose of 360 mg/m2 until disease progression, development of intolerable adverse events, or until 8 years after an individual participant has been on study
PT-112 will be administered intravenously on Days 1, 8 and 15 of a 28-day cycle at a dose of 360 mg/m2
- overall response rate (ORR) [ Time Frame: 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 ]best overall response is the best response recorded per RECIST 1.1 criteria, from the start of the treatment until disease progression/recurrence
- safety of PT-112 [ Time Frame: safety data routinely collected from initiation of study therapy through long term follow up ]type, frequency, and grade of events will be collected and reported as assessed per CTCAE criteria, version 5
- duration of response (DOR) [ Time Frame: assessed every 8 weeks while on treatment and then every 3 months ]time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
- progression-free survival (PFS) [ Time Frame: assessed every 8 weeks while on treatment and then every 3 months ]time from date of start of treatment until time of disease relapse, disease progression, or death
- overall survival (OS) [ Time Frame: during treatment and then every 3 months ]time from the date of start of treatment until death from any cause
- overall response rate (ORR) based on ITMIG modified RECIST (ITMIG) [ Time Frame: start of the treatment until disease progression/recurrence ]best overall response is the best response recorded per ITMIG modified RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05104736
|Contact: Shannon G Swift, R.N.||(240) firstname.lastname@example.org|
|Contact: Arun Rajan, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Arun Rajan, M.D.||National Cancer Institute (NCI)|