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

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2025-06-30

Brief Summary

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Study of NGM438 as Monotherapy and in Combination with Pembrolizumab 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 Cancer Esophageal Cancer Ovarian Cancer Renal Cell Carcinoma Prostate Cancer Melanoma Mesothelioma Cholangiocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NGM438 Monotherapy Dose Escalation

Part 1a Single Agent Dose Escalation

Group Type EXPERIMENTAL

NGM438

Intervention Type DRUG

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

NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )

Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )

Group Type EXPERIMENTAL

NGM438

Intervention Type DRUG

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

Pembrolizumab (KEYTRUDA ®)

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

NGM438

Intervention Type DRUG

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

Pembrolizumab (KEYTRUDA ®)

Intervention Type DRUG

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

Interventions

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NGM438

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

Intervention Type DRUG

Pembrolizumab (KEYTRUDA ®)

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

Intervention Type DRUG

Eligibility Criteria

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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.