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Monoclonal Antibodies

NGM707 + Pembrolizumab for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by NGM Biopharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy
Performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, NGM707, as a possible treatment for advanced solid tumors. It will be tested alone and in combination with another cancer drug, pembrolizumab.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors who have tried all other treatments without success, or can't tolerate them, and are in good physical condition. They must have recovered from previous therapy side effects and have proper bone marrow, kidney, and liver function.Check my eligibility
What is being tested?
The study tests NGM707 alone or combined with pembrolizumab to treat various cancers. It aims to see how well these treatments work on their own or together against different types of advanced cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, fatigue, skin issues like rash, digestive problems such as diarrhea or nausea, hormonal gland changes causing symptoms like headache or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced or has spread and was confirmed by a lab test.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of Response for Patients in Expansion Cohorts
Incidence of Adverse Events
Number of Patients in Expansion Cohorts with Objective Responses
+4 more
Secondary outcome measures
Anti-drug Antibodies (ADA) Against NGM707
Area Under the Curve (AUC) of Plasma NGM707
Observed Plasma Concentration of NGM707 (Including Cmax)
+1 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: NGM707 Monotherapy Dose Expansion Arm CExperimental Treatment1 Intervention
NGM707 in Ovarian Cancer
Group II: NGM707 Monotherapy Dose Expansion Arm BExperimental Treatment1 Intervention
NGM707 in CRC
Group III: NGM707 Monotherapy Dose Expansion Arm AExperimental Treatment1 Intervention
NGM707 in RCC
Group IV: NGM707 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part 1a Single Agent Dose Escalation
Group V: NGM707 Combination Dose Finding with pembrolizumabExperimental Treatment1 Intervention
Part 1b NGM707 plus pembrolizumab
Group VI: NGM707 Combination Dose Expansion Arm FExperimental Treatment1 Intervention
NGM707 with pembrolizumab in SCCHN
Group VII: NGM707 Combination Dose Expansion Arm EExperimental Treatment1 Intervention
NGM707 with pembrolizumab in NSCLC

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
23 Previous Clinical Trials
2,042 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,515 Total Patients Enrolled

Media Library

NGM707 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04913337 — Phase 1 & 2
Esophageal Cancer Research Study Groups: NGM707 Combination Dose Expansion Arm F, NGM707 Monotherapy Dose Escalation, NGM707 Combination Dose Finding with pembrolizumab, NGM707 Monotherapy Dose Expansion Arm A, NGM707 Monotherapy Dose Expansion Arm B, NGM707 Monotherapy Dose Expansion Arm C, NGM707 Combination Dose Expansion Arm E
Esophageal Cancer Clinical Trial 2023: NGM707 Highlights & Side Effects. Trial Name: NCT04913337 — Phase 1 & 2
NGM707 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913337 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of the prior investigations related to NGM707?

"Currently, 961 studies are underway for NGM707. Out of those investigations, 122 have reached the Phase 3 stage. The most prominent location for these trials is in Houston; however, more than 35 thousand sites across the globe are conducting clinical research on this treatment."

Answered by AI

What is the intended outcome of this medical experiment?

"As per information provided by the trial sponsor, NGM Biopharmaceuticals, Inc., the primary outcome measure of this study is Overall Survival for Patients in Expansion Cohorts of Part 2b. This will be tracked over a Baseline period up to 28 Days. Additionally, secondary outcomes including Area Under the Curve (AUC) of Plasma NGM707 - which looks at concentrations prior to the next dose - and plasma Half-Life (t1/2), as well as Anti-Drug Antibodies (ADA) against NGM707 are being monitored on Day 1 of each cycle."

Answered by AI

Are there numerous locations in Canada that are actively conducting this trial?

"To participate in this study, patients can visit Hoag Memorial Hospital Presbyterian located in Newport Beach, the University of Maryland Greenebaum Cancer Center situated in Baltimore, or Georgetown University Medical Center based out of Washington D.C., among other 13 drug trial sites."

Answered by AI

Are participants still eligible for this investigation?

"Affirmative. Clinicaltrials.gov states that this clinical trial, initially posted on June 9th 2021, is currently accepting participants. 179 individuals are needed to be recruited from 13 different sites for the study's completion."

Answered by AI

How many volunteers are allowed to partake in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research is currently enrolling participants with the initial posting date being June 9th 2021 and most recent update occurring on September 13th 2022. In total, 179 patients across thirteen sites are sought for participation in this investigation."

Answered by AI

What indications are typically addressed by NGM707?

"NGM707 is frequently employed to manage malignant neoplasms, and can be valuable in the treatment of unresectable melanoma, microsatellite instability high disease progression following chemotherapy."

Answered by AI

Who else is applying?

What site did they apply to?
Hoag Memorial Hospital Presbyterian
Prisma Health - Upstate
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
2021. "Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04913337.
All > Colorectal Cancer San Diego > Head And Neck Cancer
~37 spots leftby Feb 2025
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