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Monoclonal Antibodies

NGM438 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by NGM Biopharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type for which the patient was eligible and willing to receive
Performance status of 0 or 1
Must not have
Prior treatment targeting LAIR1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, NGM438, 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 who have tried all other treatments without success. They should be in good physical condition (able to perform daily activities) and have normal bone marrow, kidney, and liver function. People can't join if they've previously received treatment targeting LAIR1.
What is being tested?
The study is testing NGM438 alone and combined with Pembrolizumab on various cancers like lung, breast, prostate, melanoma, etc., to see how well these treatments work against advanced stages of the diseases.
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, fatigue, skin issues like rash or itchiness, flu-like symptoms such as fever or chills; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not respond or I couldn't tolerate all treatments I was eligible for.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced or has spread and was confirmed by a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received treatments targeting LAIR1.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Adverse Events
Number of Patients with Clinically Significant Laboratory Abnormalities
Number of Patients with Dose-limiting Toxicities
Secondary study objectives
Anti-drug Antibodies (ADA) Against NGM438
Area Under the Curve (AUC) of Serum NGM438
Half-life (t1/2) of NGM438 in Serum
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: NGM438 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part 1a Single Agent Dose Escalation
Group II: NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )Experimental Treatment2 Interventions
Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )
Group III: Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®)Experimental Treatment2 Interventions
Part 1C NGM438 followed by NGM438 plus pembrolizumab ( KEYTRUDA ® )

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
24 Previous Clinical Trials
2,465 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,732 Total Patients Enrolled

Media Library

NGM438 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05311618 — Phase 1
Squamous Cell Carcinoma Clinical Trial 2023: NGM438 Highlights & Side Effects. Trial Name: NCT05311618 — Phase 1
Squamous Cell Carcinoma Research Study Groups: NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® ), Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®), NGM438 Monotherapy Dose Escalation
NGM438 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05311618 — Phase 1
~6 spots leftby Apr 2025
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