A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 13, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Ovarian CancerMelanomaTriple Negative Breast CancerColorectal Cancer
Interventions
DRUG

NM1F 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."

DRUG

Pembrolizumab 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."

Trial Locations (2)

22031

RECRUITING

Next Oncology, Virginia Cancer Specialists, Fairfax

75039

RECRUITING

NEXT Oncology, Dallas, Dallas

All Listed Sponsors
lead

Hefei TG ImmunoPharma Co., Ltd.

OTHER