Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NM1F Injection
NM1F · 1 trial · 4 indications
The incidence of DLTs during the DLT assessment period.
Determination of the MTD or maximum tested dose, and the RP2D.
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
| Arm | Type | Description |
|---|---|---|
| NM1F Injection/pembrolizumab Injection | EXPERIMENTAL | NM1F monotherapy dose escalation(Phase 1a) NM1F dose escalation in combination with a fixed dose of pembrolizumab(Phase 1b) |
| Name | Type | Description |
|---|---|---|
| NM1F Injection | DRUG | 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. |
| Pembrolizumab injection | DRUG | 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. |
Inclusion Criteria: 1. Male or female subjects age ≥ 18 years at the time of informed consent. 2. 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...
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NM1F is an investigational small molecule being studied for the treatment of ovarian cancer. It is also being evaluated in patients with melanoma, triple negative breast cancer, and colorectal cancer as part of an early-stage clinical trial. The drug is administered by injection and is currently in Phase 1 development.
NM1F targets PVRIG, a protein involved in immune regulation. By targeting PVRIG, the drug is designed to modulate the immune response against tumors. This mechanism is being investigated in a first-in-human study for advanced solid tumors, including ovarian cancer.
NM1F is being developed by TG Therapeutics, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol TGTX. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of NM1F in patients with advanced solid tumors.
NM1F is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. The ongoing Phase 1 trial is a first-in-human, open-label, multicenter study designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
NM1F is being studied in a Phase 1 clinical trial with the identifier NCT05746897. This is a first-in-human, open-label, multicenter study enrolling approximately 38 patients with advanced solid tumors, including ovarian cancer, melanoma, triple negative breast cancer, and colorectal cancer. The trial is currently recruiting participants in the United States.
Yes, NM1F is also known as NM1F Injection. The drug is administered via injection, and both names refer to the same investigational therapy being developed by TG Therapeutics, Inc. for the treatment of advanced solid tumors, including ovarian cancer.