← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My cancer did not respond or I couldn't tolerate all treatments I was eligible for.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My cancer is advanced or has spread and was confirmed by a lab test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163

Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8

Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9

+3 more

Secondary outcome measures

Anti-drug Antibodies (ADA) Against NGM438

Area Under the Curve (AUC) of Serum NGM438

Half-life (t1/2) of NGM438 in Serum

+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 ® )

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor

23 Previous Clinical Trials

2,150 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,482 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

Frequently Asked Questions

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

What is the size of the sample pool being examined in this experiment?

"This trial requires 71 individuals who meet the required conditions to join. Those interested in participating can do so from different medical centres, such as Henry Ford Health System (Detroit MI) and Yale Cancer Center (New Haven CT)."

Answered by AI

Does this clinical trial currently have openings for participation?

"This medical trial is open for recruitment, as indicated by the clinicaltrials.gov record which was initially posted on May 11th 2022 and modified lastly on October 6th of that same year."

Answered by AI

Has NGM438 been cleared by the Food and Drug Administration?

"NGM438's safety is judged at a 1 on our team's scale, as this Phase 1 trial has only limited evidence supporting its efficacy and security."

Answered by AI

How many locations are currently facilitating this experiment?

"Currently, 5 distinct clinical trial sites are recruiting patients. Those locations encompass Detroit and New Haven as well as Houston with an additional 5 other cities included in the study. Enrollees should select a site that is most proximate to them to reduce travel demands."

Answered by AI

What aims is this clinical research seeking to accomplish?

"The primary aim of this 24-month research project is to monitor the alterations in CD163, a pharmacodynamic biomarker, within paired tumor tissue from participants enrolled into the Biopsy Cohort. Secondary objectives include assessing occurrences and titres of anti-drug antibodies against NGM438 over 6 cycles; noting Tmax (time to reach peak serum concentration) on specified days during each cycle; and calculating systemic clearance of NGM438 also at predetermined points throughout each cycle."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05311618.

All > Intrahepatic Cholangiocarcinoma > Head And Neck Cancer