A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHefei TG ImmunoPharma Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects age ≥ 18 years at the time of informed consent.
Subjects with histologically or cytologically diagnosed unresectable locally advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC, melanoma, OC, and who have progressed despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists
Subjects must have at least 1 evaluable lesion as defined by response evaluation criteria in solid tumors (RECIST) v1.1.
ECOG PS of 0~2.
Disqualifiers
Subject with known active central nervous system (CNS) primary tumor or metastases.
History of intercurrent severe chronic or active infections.
Has a history of active autoimmune diseases , or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study drug.
Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
Trial design
Design model
Single group
Treatments tested in this trial
NM1F Injection
DrugThis 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.
Pembrolizumab injection
DrugThis 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: NM1F Injection/pembrolizumab InjectionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Time frame
First 21 days of treatment.2
Dose-Finding
Determination of the MTD or maximum tested dose, and the RP2D.
Time frame
Approximately 3 years.3
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 doseSecondary outcomes
1
Pharmacokinetics of NM1F
Maximum Plasma Concentration (Cmax)
Time frame
Day 1 of dosing through 30 days post last dose2
Pharmacokinetics of NM1F
Area Under the Curve (AUC)
Time frame
Day 1 of dosing through 30 days post last dose3
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 dose4
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Time frame
Approximately 3 years.Sponsors and contacts
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Source ClinicalTrials.gov