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New treatment option for Thymic Epithelial Tumor
Official title PT-112 in Subjects With Thymoma and Thymic Carcinoma
ClinicalTrials.gov ID: NCT05104736
What this study is testing
What is PT-112?
PT-112 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thymic epithelial tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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...
- 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.
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PT-112. Since there is no definitive list of...
- Concurrent treatment with a non-permitted drug.
- Concurrent anticancer treatment within 14 days before initiation of study therapy (includes radiotherapy; however, palliative bone-directed...
- Major surgery within 14 days before enrollment (excluding prior diagnostic biopsy).
- Concurrent systemic therapy with immunosuppressive agents within 14 days (or 5 half-lives of a drug, whichever is shorter) before initiation of study...
- Use of hormonal agents for anti-cancer therapy within 14 days before initiation of study therapy; or use of any investigational drug within 14 days...
See the full eligibility criteria
Who can join
- 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...
- 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 undergone successful surgical...
- Participants must not become pregnant or start breast feeding during the study. Breastfeeding should be discontinued if the mother is treated with PT-112.
- Individuals of child-bearing potential and those that can father children with a sexual partner of childbearing potential must use medically effective contraception during the study and for 6 months after the last dose...
- Participants with previously treated brain or CNS metastases are eligible provided that the participant has recovered from any acute side effects of radiotherapy and does not require treatment with steroids, and any...
- Ability of participant to understand and the willingness to sign a written informed consent document.
What rules you out
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PT-112. Since there is no definitive list of compounds of similar chemical or biologic composition to PT-112, the...
- Concurrent treatment with a non-permitted drug.
- Concurrent anticancer treatment within 14 days before initiation of study therapy (includes radiotherapy; however, palliative bone-directed radiotherapy is permitted).
- Major surgery within 14 days before enrollment (excluding prior diagnostic biopsy).
- Concurrent systemic therapy with immunosuppressive agents within 14 days (or 5 half-lives of a drug, whichever is shorter) before initiation of study therapy.
- Use of hormonal agents for anti-cancer therapy within 14 days before initiation of study therapy; or use of any investigational drug within 14 days before initiation of study therapy.
- History of previous malignant disease within the last 2 years with the following exceptions: basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary or...
- Active infection requiring systemic therapy or significant acute or chronic infections including, among others:
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
- Known history of testing positive for HIV or known acquired immunodeficiency syndrome with a detectable viral load. However, participants with HIV who have an undetectable viral load and are on stable doses of Highly...
- Persisting toxicity related to prior therapy (NCI CTCAE v. 5 Grade \> 1) with the exception of, alopecia, sensory neuropathy Grade \<= 2 and hearing loss Grade \<=2.
- Known alcohol or drug abuse.
- Uncontrolled intercurrent illness including, but not limited to the following:
- Cardiovascular: SYMPTOMATIC congestive heart failure, unstable angina pectoris or cardiac arrhythmia, either active or within the past 6 months
- Respiratory: Pneumonitis or Idiopathic pulmonary fibrosis (not radiation-associated fibrosis), either active or within the past 6 months
- Gastrointestinal: Immune colitis or inflammatory bowel disease, either active or within the past 6 months
- Hematological: Bleeding diathesis or major bleeding events, either active or within the past 6 months
- Other: psychiatric illness/social situations that would limit compliance with study requirements, including active suicidal ideation or behavior, either active or within the past 12 months
- Administration of live vaccines within 4 weeks prior to treatment. COVID-19 vaccines are permitted at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.