CRC
Conditions
Brief summary
Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Interventions
DRUGNGM707 plus pembrolizumab
Drug: NGM707 NGM707 will be administered intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. * Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * Have at least 1 measurable lesion per RECIST v1.1 criteria. * 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 AEs not constituting a safety risk by Investigator judgement.
Exclusion criteria
* Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) as per RECIST v1.1 | Baseline up to approximately 24 months | 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 |
| Incidence of Adverse Events | Baseline up to Approximately 24 Months | 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. |
Contacts
STUDY_DIRECTORChief Medical Officer
NGM Biopharmaceuticals, Inc
Outcome results
None listed