Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04913337 | Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 179 | — | — | Jun 9, 2021 | Jul 1, 2025 | Oct 2, 2024 | 27 | United States, South Korea +1 |
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 28 days after the first dose of study treatment.
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug 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.
Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.
Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| NGM707 Monotherapy Dose Escalation | EXPERIMENTAL | Part 1a Single Agent Dose Escalation |
| NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | EXPERIMENTAL | Part 1b NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Combination Dose Expansion Arm A | EXPERIMENTAL | NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC |
| NGM707 Combination Dose Expansion Arm B | EXPERIMENTAL | NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC |
| NGM707 Combination Dose Expansion Arm C | EXPERIMENTAL | NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN |
| NGM707 Monotherapy Dose Expansion Arm D | EXPERIMENTAL | NGM707 in RCC |
| NGM707 Monotherapy Dose Expansion Arm E | EXPERIMENTAL | NGM707 in CRC |
| NGM707 Monotherapy Dose Expansion Arm F | EXPERIMENTAL | NGM707 in Ovarian |
| Name | Type | Description |
|---|---|---|
| NGM707 | DRUG | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
| NGM707 plus pembrolizumab (KEYTRUDA®) | DRUG | Drug: NGM707 NGM707 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. * Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to ...