- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511972
Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
A Phase 2 Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study Overview
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NGM707 Combination Cohort A
NGM707 with pembrolizumab in MSS CRC
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Adverse Events
Time Frame: 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. |
Baseline up to Approximately 24 Months
|
|
Objective response rate (ORR) as per RECIST v1.1
Time Frame: 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
|
Baseline up to approximately 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chief Medical Officer, NGM Biopharmaceuticals, Inc
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 707-IO-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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