A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors. The study consists of two parts : NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (1 year and 2 years for Phase 1a and 1b, respectively, or until treatment discontinuation), and a follow-up period .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors. The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period.
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors. The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period.
NEXT Oncology, Dallas
Dallas, Texas, United States
RECRUITINGNext Oncology, Virginia Cancer Specialists
Fairfax, Virginia, United States
RECRUITINGDose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Time frame: First 21 days of treatment.
Dose-Finding
Determination of the MTD or maximum tested dose, and the RP2D.
Time frame: Approximately 3 years.
Frequency and Severity of Adverse Events (AE)
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Time frame: Screening to 30 days from last dose
Pharmacokinetics of NM1F
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 of dosing through 30 days post last dose
Pharmacokinetics of NM1F
Area Under the Curve (AUC)
Time frame: Day 1 of dosing through 30 days post last dose
Number of subjects with Anti-NM1F antibody positive .
Immunogenicity of NM1F monotherapy and in combination with pembrolizumab
Time frame: Day 1 of dosing through 30 days post last dose
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Time frame: Approximately 3 years.
Duration of Response (DoR)
Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for progressive disease.
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Time frame: Approximately 3 years.
Disease Control Rate (DCR)
The proportion of subjects who have best overall response of CR or PR, or stable disease (SD).
Time frame: Approximately 3 years.
Progression Free Survival (PFS)
Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.
Time frame: Approximately 3 years.
Overall Survival (OS)
Time from the date of initiation of study therapy to the date of death from any cause.
Time frame: Approximately 3 years.