Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Study Purpose

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

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, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.

- 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 ILT2 and/or ILT4 or targeting HLA-G.

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.	NCT04913337
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/Phase 2
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	Recruiting
Countries	Korea, Republic of, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Mesothelioma, Glioblastoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma, Breast Cancer, Ovarian Cancer, Cervical Cancer, Endocervical Cancer, Colorectal Cancer, Esophageal Cancer

Arms & Interventions

Arms

Experimental: NGM707 Monotherapy Dose Escalation

Part 1a Single Agent Dose Escalation

Experimental: NGM707 Combination Dose Finding with pembrolizumab

Part 1b NGM707 plus pembrolizumab

Experimental: NGM707 Monotherapy Dose Expansion Arm A

NGM707 in RCC

Experimental: NGM707 Monotherapy Dose Expansion Arm B

NGM707 in CRC

Experimental: NGM707 Monotherapy Dose Expansion Arm C

NGM707 in Ovarian Cancer

Experimental: NGM707 Combination Dose Expansion Arm E

NGM707 with pembrolizumab in NSCLC

Experimental: NGM707 Combination Dose Expansion Arm F

NGM707 with pembrolizumab in SCCHN

Interventions

Drug: - NGM707

Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

Drug: - NGM707 plus pembrolizumab

Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: - NGM707

Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: - NGM707

Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: - NGM707

Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: - NGM707 plus pembrolizumab

Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: - NGM707 plus pembrolizumab

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.

University of Southern California, Los Angeles, California

Status

Recruiting

Address

University of Southern California

Los Angeles, California, 90033

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