Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NGM831 · 1 trial · 16 indications
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Number of patients with treatment-emergent adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
| Arm | Type | Description |
|---|---|---|
| NGM831 Monotherapy Dose Escalation | EXPERIMENTAL | Part 1a Single Agent Dose Escalation |
| NGM831 combination dose finding with pembrolizumab (KEYTRUDA®) | EXPERIMENTAL | Part 1b NGM831 plus pembrolizumab (KEYTRUDA®) |
| NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | EXPERIMENTAL | Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) |
| Name | Type | Description |
|---|---|---|
| NGM831 | DRUG | Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
| NGM831 plus pembrolizumab (KEYTRUDA®) | DRUG | Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle. |
| NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) | DRUG | Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: NGM438 NGM438 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21-day cycle. |
Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. * Adequate bone marrow, kidney and liver function * Performance status of 0 or 1. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AE...
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