This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.
Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR ).
Documented evidence of advanced (Stage III or IV), or recurrent EC.
Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation
Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.
Brain metastasis: Previously treated CNS disease needs to be asymptomatic and does not require steroids. Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.
Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.
Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.
Except for the allowance of ongoing use of Len+Pem, the protocol excludes patients having received any other prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.
Sequential
EG-007
DrugA Repurposed Drug
Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection
DrugPembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.
Lenvatinib Capsules
DrugLenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc.
Adverse Events Assessment using CTCAE v5.0
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment. Data Monitoring committee review for safety to proceed through dose escalation.
Tolerability Score measurement using NCI-PRO CTCAE
Using NCI-PRO CTCAE to record the tolerability score for patients to evaluate symptomatic toxicities.
Long-term Safety Monitoring for EG-007 plus Len+Pem
To conduct long-term monitoring of the safety and clinical outcomes for EG-007 plus Len+Pem. The proportion of Participants With Treatment-Related Adverse Events during long-term monitoring.
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This trial is not recruiting at the moment. You can still explore other options:
