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Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
  • - 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.
  • - 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 LAIR1

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05311618
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NGM Biopharmaceuticals, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pancreatic Cancer, Breast Cancer, Gastric Cancer, Non Small Cell Lung Cancer, Cervical Cancer, Endocervical Cancer, Squamous Cell Carcinoma of Head and Neck, Bladder Urothelial Cancer, Colorectal Cancer, Esophageal Cancer, Ovarian Cancer, Renal Cell Carcinoma, Prostate Cancer, Melanoma, Mesothelioma, Cholangiocarcinoma
Arms & Interventions

Arms

Experimental: NGM438 Monotherapy Dose Escalation

Part 1a Single Agent Dose Escalation

Experimental: NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )

Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )

Experimental: Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®)

Part 1C NGM438 followed by NGM438 plus pembrolizumab ( KEYTRUDA ® )

Interventions

Drug: - NGM438

NGM438 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

Drug: - Pembrolizumab (KEYTRUDA ®)

Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

SCRI Denver, Denver 5419384, Colorado 5417618

Status

Address

SCRI Denver

Denver 5419384, Colorado 5417618, 80218

Yale Cancer Center, New Haven 4839366, Connecticut 4831725

Status

Address

Yale Cancer Center

New Haven 4839366, Connecticut 4831725, 06520

Henry Ford Health System, Detroit 4990729, Michigan 5001836

Status

Address

Henry Ford Health System

Detroit 4990729, Michigan 5001836, 48202

START Midwest, Grand Rapids 4994358, Michigan 5001836

Status

Address

START Midwest

Grand Rapids 4994358, Michigan 5001836, 49546

Mount Sinai Hospital, New York 5128581, New York 5128638

Status

Address

Mount Sinai Hospital

New York 5128581, New York 5128638, 10029

MD Anderson, Houston 4699066, Texas 4736286

Status

Address

MD Anderson

Houston 4699066, Texas 4736286, 77030

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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