PT-112 in Subjects With Thymoma and Thymic Carcinoma

Thymic Epithelial Tumor Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Background

Platinum-based chemotherapy is the standard of care for advanced unresectable thymic epithelial tumors (TETs). However, more than half of these participants 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 participants 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 at a dose of 360 mg/m2 on days 1 and 15 of cycle 1, and at 250 mg/m2 on day 1 of each subsequent cycle, until disease progression or development of intolerable adverse events. Each cycle is 28 days.

For participants who develop intolerable toxicity at a dose of 360 mg/m2, dose reduction will be permitted to 300 mg/m2 after resolution of adverse events to <= grade 1 or baseline. For

participants who develop intolerable toxicity at a dose of 250 mg/m2, up to two dose reductions will be permitted to 200 mg/m2 or 150 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. ;

Related Conditions & MeSH terms

• Recurrent Thymoma
• Thymic Cancer
• Thymic Epithelial Tumor
• Thymoma
• Thymus Neoplasms

• NCT number: NCT05104736
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Shannon G Swift, R.N.
• Phone: (240) 858-3157
• Email: shannon.swift@nih.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: April 6, 2022
• Completion date: June 30, 2025