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The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg.
The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.
Full description
The experimental drug called NEO-201 (the "study drug") is a monoclonal antibody that is being tested and is not approved for use in the United States by the FDA.
As stated above the RP2D was determined at 1.5 mg/kg and in the current Expansion Phase it will be administered in combination with pembrolizumab. .
A safety lead in will be conducted in the first 3 to 6 subjects to evaluate toxicity prior to expanding accrual. The safety lead-in will be 42 days in length, consisting of 1 dose of pembrolizumab and 3 doses of NEO-201 followed by a 2-week assessment for safety, in subjects with any of the expansion cohorts' targeted disease types. The third patient in the safety lead in must complete the 30-day assessment (1 dose of pembrolizumab and 3 doses of NEO-201 followed by a 2-week safety evaluation) and be evaluated for toxicity prior to treating additional patients.
Following completion of the lead-in, expansion cohorts will accrue subjects with NSCLC, HNSCC, cervical and uterine cancers who progress on frontline therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age: >/=18 years
Diagnosis:
Tumor has the additional characteristics described below for the disease specific expansion cohorts:
NSCLC:
Cervical Cancer:
• Tumor(s) express a combined positive score (CPS) > 1, as determined by an FDA approved test and/or is microsatellite instability-high (MSI-H) or mismatch repair deficient, and/or is tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)], as determined by an FDA-approved test
HNSCC • Patients are allowed to have received pembrolizumab previously, either alone or as part of a multiagent regimen.
Uterine carcinoma
• Patients who are eligible to have received the combination of pembrolizumab plus lenvatinib (i.e. patients with tumors that are not MSI or dMMR) must have received this regimen, unless considered unsafe due to comorbid conditions (e.g. hypertension, proteinuria).
Must have archived tissue (10 unstained slides or tissue block), or must have tumor which can be safely biopsied percutaneously and be willing to undergo a tumor biopsy
MEASURABLE/EVALUABLE DISEASE: Measurable disease (by RECISTv1.1)
INFORMED CONSENT: Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
PERFORMANCE STATUS: ECOG ≤ 2; or Karnofsky performance status of ≥ 50%
LABORATORY FUNCTION:
PRIOR THERAPY:
Subjects must have recovered from any acute toxicity related to prior therapy, except for alopecia. Toxicity should be ≤ grade 1, or ≤ grade 2 for peripheral neuropathy, or hypothyroidism
Subject is expected to be able to remain on a study protocol for at least 8 weeks
BIRTH CONTROL: Female subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study, and 2 weeks after completion of NEO-201 administration or 4 months after the last dose of pembrolizumab (according to package labeling), whichever is later.
Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after completion of NEO-201 administration or 4 months after the last dose of pembrolizumab (according to package labeling), whichever is later.
Exclusion criteria
Additional Exclusion Criteria for Expansion Cohorts
Because patients in the expansion cohort will be receiving pembrolizumab, the following additional exclusion criteria apply:
Primary purpose
Allocation
Interventional model
Masking
121 participants in 1 patient group
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Central trial contact
Ann McCoy, RN; Erica Redmond, BSN,RN
Data sourced from clinicaltrials.gov
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