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
Qualifiers
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
Treatments tested in this trial
- NM1F Injection
- Pembrolizumab injection
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov