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Monoclonal Antibodies

NGM831 + Pembrolizumab for Cancer

Phase 1

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 baseline up to approximately 24 months

Awards & highlights

Study Summary

This trial is testing a new drug, NGM831, as a possible treatment for advanced or metastatic solid tumors.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including various cancers like lung, breast, and colorectal cancer. Participants should be in good physical condition (performance status of 0 or 1) and have recovered from previous treatments' acute effects. They must also have adequate bone marrow, kidney, and liver function. Those who've had prior treatment targeting ILT3 cannot join.Check my eligibility

What is being tested?

The study is testing NGM831 on its own and combined with pembrolizumab to see how well they work against different types of advanced cancers. The goal is to find out if these treatments can help control the growth of cancer cells.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to pembrolizumab's action on the immune system; this could lead to inflammation in organs like the lungs or colon. Other common side effects might involve fatigue, skin issues, nausea, and changes in blood tests.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 24 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

Incidence of Adverse Events

Number of Patients with Dose-limiting Toxicities

Secondary outcome measures

Anti-drug Antibodies (ADA) Against NGM438

Anti-drug Antibodies (ADA) Against NGM831

Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)Experimental Treatment1 Intervention

Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

Group II: NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)Experimental Treatment1 Intervention

Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Group III: NGM831 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Part 1a Single Agent Dose Escalation

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor

23 Previous Clinical Trials

2,091 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,874 Total Patients Enrolled

Media Library

NGM831 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05215574 — Phase 1

Oral Squamous Cell Carcinoma Clinical Trial 2023: NGM831 Highlights & Side Effects. Trial Name: NCT05215574 — Phase 1

Oral Squamous Cell Carcinoma Research Study Groups: NGM831 combination dose finding with pembrolizumab (KEYTRUDA®), NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®), NGM831 Monotherapy Dose Escalation

NGM831 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05215574 — Phase 1

Frequently Asked Questions

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

How many facilities have this trial underway?

"There are 7 operating sites in total, such as Florida Cancer Specialists in Sarasota, The Angeles Clinic in Los Angeles, and Next Oncology in Austin. Additionally there are 4 other destinations offering this trial."

Answered by AI

Is there still availability for participants to join this investigation?

"Affirmative, the information on clinicaltrials.gov indicates that this trial is currently enlisting participants. The experiment was initially posted on March 31st 2022 and recently updated on November 3rd 2022. Approximately 79 patients need to be enrolled from 7 distinct sites."

Answered by AI

What is the total participant count of this clinical investigation?

"This clinical trial requires 79 suitable individuals who meet the eligibility requirements. Patients may join this investigation at either Florida Cancer Specialists in Sarasota, FL or The Angeles Clinic located in Los Angeles, CA."

Answered by AI

Can patients expect adverse effects from being administered NGM831?

"Our team assigned NGM831 a score of 1 because the clinical trial for this drug is currently in Phase 1, meaning there are only preliminary data points supporting its safety and efficacy."

Answered by AI

What are the major goals of this research?

"The primary aim of this clinical trial, evaluated over a timespan between Baseline and 21 Days, is to determine the amount of patients displaying clinically noteworthy laboratory abnormalities. Secondary objectives include ascertaining the Time-to-Maximum Concentration (Tmax) of NGM831 at Day 1, 2, 4, 8 and 15 in Cycles 1 & 3; Day 1 in Cycle 2; and Day 1 for every subsequent cycle examined as well Maximum Observed Serum Concentrations (Cmax), plus Trough concentrations before drug administration on the same days mentioned above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

2022. "Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05215574.

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