Status and phase
Conditions
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About
This Phase 1 study will evaluate the safety and tolerability of [Ga-68]-PNT6555 and [Lu-177]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Adult (>18 years) male and female patients
Females of childbearing potential and males and their female partner(s) of childbearing potential must use two acceptable forms of contraception, one being a barrier method, during the study and also for 31 weeks (females) or 18 weeks (males) after last study drug administration.
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
The patient has read, understood, and signed the written informed consent form(s)
Advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy:
Laboratory values at initial screening and also within three days prior to dosing of [Lu-177]-PNT6555:
Platelets greater than 120,000/ mm^3 at dosing. Transfusions allowed, but not for first dose
Neutrophils greater than 1500cells/mm^3
Hemoglobin:
Liver Chemistries:
Normal PT(secs) and aPTT(sec); normal INR (ratio). Patients taking anticoagulants must be in therapeutic range
Glomerular filtration rate defined as creatinine clearance >60 ml/min/1.73 m2 based on Cockcroft-Gault formula
Life expectancy of at least 6 months per investigator judgement
Eastern Cooperative Oncology Group (ECOG) 0 to 1
Patients must have previously received treatment for their underlying disease and have no potentially curative options available
Positive [Ga-68]-PNT6555 PET/CT scan, defined as at least 50% of lesions with an SUVmax of 1.5 times or greater the SUVmean of the liver
Exclusion criteria
Patient has metastatic brain disease
Women who are pregnant, lactating, or planning to attempt to become pregnant during the study or within 31 weeks after last administration of study drug
Males with female partners who are pregnant, lactating or planning to attempt to become pregnant during this study or within 18 weeks after last administration of study drug
Subject has received prior hemi- or total- body radiation
Subject has received whole brain radiation
History of any grade 4 myelosuppression, or grade 3 myelosuppression requiring more than 6 weeks recovery
History of any kidney dysfunction (e.g., acute kidney failure, acute tubular necrosis (ATN)) for any reason (only in US)
Secondary malignancy that may interfere with the safety assessments of this study
Patient has any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities
a. Or the patient has persistent NCI-CTCAE version 5.0 Grade ≥ 2 toxicity due to prior cancer therapy. Permitted exceptions include Grade 2 neuropathy, alopecia, endocrinopathy with replacement therapy, and anemia (only in US)
Patient has received any other investigational agents within 4 weeks of starting the study treatment
Patient has received systemic anti-cancer therapy:
Patient has undergone surgery within 4 weeks of starting the study treatment; exceptions are permitted with approval by Medical Monitor
Previous radioligand therapy
Previous Adoptive T-Cell Therapy (e.g. CAR-T therapy, TCR therapy, etc.)
Prolonged QT, defined as QTc > 470 ms regardless of sex (only in US)
In patients who have received prior EBRT, each case should be reviewed by the site Investigators to determine appropriateness of eligibility given potential increased risk for radiation toxicities. In patients who have received a prior course of radiation therapy adjacent to either kidney, the mean kidney dose from EBRT must be available to inform potential risk, otherwise the patient will be ineligible. Patients who have previously exceeded dose limits for critical organs from prior EBRT are ineligible (only in US)
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Central trial contact
Richard Cioci
Data sourced from clinicaltrials.gov
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