What side effects are associated with this type of intervention?

Common treatments for Thymic Epithelial Tumors, particularly those that kill cancer cells and enhance the immune response, include chemotherapy and immunotherapy. Chemotherapy side effects often include nausea, vomiting, diarrhea, hand-foot syndrome, and myelosuppression. Immunotherapy can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. PT-112, which is being studied for its dual action, may share similar side effects.

What prior FDA approvals exist?

There are no FDA-approved drugs specifically for the treatment of recurrent thymoma and thymic carcinoma that directly match the dual mechanism of PT-112 (killing cancer cells and enhancing immune response). However, immunotherapy agents like pembrolizumab, which enhances the immune response, have been explored in various cancers, including thymic epithelial tumors. Additionally, chemotherapy agents that kill cancer cells are commonly used in treatment regimens for these tumors.

What other types of research exist?

Promising novel alternatives to PT-112 for Thymic Epithelial Tumors include thymosin-alpha 1 and tumor-targeted interleukin 12 (ttIL-12) gene therapy. Both therapies have shown potential in enhancing immune response and targeting cancer cells.

← Back to Search

Anti-tumor antibiotic

PT-112 for Thymic Cancer

Phase 2

Recruiting

Led By Arun Rajan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- creatinine <= 1.5x ULN OR: creatinine clearance >= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab

- Female participants must not become pregnant or start breast feeding during the study. Breastfeeding should be discontinued if the mother is treated with PT-112.

Must not have

Major surgery within 14 days before enrollment (excluding prior diagnostic biopsy).

- Cardiovascular: SYMPTOMATIC congestive heart failure, unstable angina pectoris or cardiac arrhythmia, either active or within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called PT-112 to see if it can shrink tumors in adults with thymoma or thymic cancer that has come back or gotten worse after other treatments. PT-112 kills cancer cells and helps the immune system fight the cancer. The study will monitor patients' responses and side effects.

Who is the study for?

Adults aged 18+ with thymoma or thymic carcinoma that has returned or worsened after platinum-based chemotherapy, or those who refused standard treatment. They must have measurable disease, adequate organ and marrow function, and not be pregnant or breastfeeding. Contraception is required for participants of childbearing potential.

What is being tested?

The trial tests PT-112, a drug designed to kill cancer cells and boost the immune system's ability to fight cancer. Participants will receive PT-112 through an infusion on specific days in a 28-day cycle and will continue as long as they tolerate side effects without worsening of their disease.

What are the potential side effects?

While the exact side effects are not listed here, common ones may include reactions at the infusion site, fatigue, changes in blood counts affecting immunity and clotting, heart issues detectable by ECG (as monitored), plus any general risks associated with biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function, measured by creatinine levels or clearance, is within the required range.

Select...

I am not pregnant or breastfeeding, and will not become pregnant during the study.

Select...

My cancer is confirmed to be thymoma or thymic carcinoma.

Select...

I am not pregnant and either cannot have children or am not currently able to.

Select...

My cancer has worsened and cannot be removed with surgery.

Select...

My liver enzymes are within the required range.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had major surgery in the last 2 weeks.

Select...

I have not had serious heart problems like heart failure, chest pain, or irregular heartbeat in the last 6 months.

Select...

I haven't had immune colitis or inflammatory bowel disease in the last 6 months.

Select...

I haven't had major bleeding or bleeding disorders in the last 6 months.

Select...

I have had pneumonitis or idiopathic pulmonary fibrosis in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

overall response rate (ORR)

Secondary study objectives

duration of response (DOR)

overall response rate (ORR) based on ITMIG modified RECIST (ITMIG)

overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PT-112Experimental Treatment1 Intervention

PT-112 will be administered intravenously in 28-day cycles, on Days 1 and 15 at a dose of 360 mg/m2 for cycle 1, and on day 1 at 250mg/m2 for each subsequent cycle, until disease progression, development of intolerable adverse events, or until 8 years after an individual participant has been on study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PT-112

2017

Completed Phase 2

~100

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Thymic Epithelial Tumors (TETs) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, which can help reduce tumor size and slow disease progression. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, leading to their destruction while sparing normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells by blocking proteins that inhibit immune activity. These mechanisms are crucial for TET patients as they offer multiple avenues to control tumor growth, improve survival rates, and potentially lead to better treatment outcomes by leveraging both direct cancer cell killing and immune system activation.

Aberrant epigenetic regulation: a central contributor to lung carcinogenesis and a new therapeutic target.