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Study of NGM831 as Monotherap...

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

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2026-03-31

Brief Summary

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

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Detailed Description

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Conditions

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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 Carcinoma Esophageal Cancer Ovarian Cancer Renal Cell Carcinoma Prostate Cancer Melanoma Mesothelioma Cholangiocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NGM831 Monotherapy Dose Escalation

Part 1a Single Agent Dose Escalation

Group Type EXPERIMENTAL

NGM831

Intervention Type DRUG

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)

Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

Group Type EXPERIMENTAL

NGM831 plus pembrolizumab (KEYTRUDA®)

Intervention Type DRUG

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated.

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

NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)

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

Group Type EXPERIMENTAL

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Intervention Type DRUG

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated.

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.

Interventions

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NGM831

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

Intervention Type DRUG

NGM831 plus pembrolizumab (KEYTRUDA®)

Intervention Type DRUG

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
* 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.