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
Summary
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
Detailed description
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 .
Arms & interventions
- DrugNM1F Injection
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.
- DrugPembrolizumab injection
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.
Outcome measures
Primary
Dose-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
Secondary
Pharmacokinetics of NM1F
Time frame: Day 1 of dosing through 30 days post last dose
Pharmacokinetics of NM1F
Time frame: Day 1 of dosing through 30 days post last dose
Number of subjects with Anti-NM1F antibody positive .
Time frame: Day 1 of dosing through 30 days post last dose
Objective Response Rate (ORR)
Time frame: Approximately 3 years.
Duration of Response (DoR)
Time frame: Approximately 3 years.
Disease Control Rate (DCR)
Time frame: Approximately 3 years.
Progression Free Survival (PFS)
Time frame: Approximately 3 years.
Overall Survival (OS)
Time frame: Approximately 3 years.
Eligibility criteria
Study locations (2)
NEXT Oncology, Dallas
Dallas, Texas, 75039
Next Oncology, Virginia Cancer Specialists
Fairfax, Virginia, 22031