Symptoms and General Pathology

All Conditions

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Nervous System Diseases

Blood and Lymph Conditions

Rare Diseases

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Carcinoma

Peripheral Nervous System Diseases

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Thymic Epithelial Tumor

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

PT-112

Shannon G Swift, R.N.

Arun Rajan, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

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 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.

Background

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.

Primary Objectives

To determine the objective response rate (ORR) based on RECIST criteria v1.1 to PT-112 in patients with relapsed or refractory TETs.

Eligibility

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

Design

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.

PT-112 in Subjects With Thymoma and Thymic Carcinoma

A Phase II, Open-Label Trial of PT-112 in Subjects With Thymoma and Thymic Carcinoma

.All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

best overall response is the best response recorded per RECIST 1.1 criteria, from the start of the treatment until disease progression/recurrence

type, frequency, and grade of events will be collected and reported as assessed per CTCAE criteria, version 5

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

time from date of start of treatment until time of disease relapse, disease progression, or death

time from the date of start of treatment until death from any cause

best overall response is the best response recorded per ITMIG modified RECIST criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PT-112 in Subjects With Thymoma and Thymic Carcinoma	NCT05104736	Thymic Epitheli... Recurrent Thymo... Thymic Cancer	PT-112	18 Years -	National Institutes of Health Clinical Center (CC)
PT-112 in Subjects With Thymoma and Thymic Carcinoma	NCT05104736	Thymic Epitheli... Recurrent Thymo... Thymic Cancer	PT-112	18 Years -	National Institutes of Health Clinical Center (CC)

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