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

Phase 2WithdrawnNCT07511972

NGM Biopharmaceuticals, Inc

Overview

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

CRC

Interventions

NGM707 plus pembrolizumabDRUG

Drug: NGM707 NGM707 will be administered 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. * Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * Have at least 1 measurable lesion per RECIST v1.1 criteria. * 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.

Outcomes

Primary Outcomes

Objective response rate (ORR) as per RECIST v1.1

Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1

Time frame: Baseline up to approximately 24 months

Incidence of Adverse Events

Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.

Time frame: Baseline up to Approximately 24 Months

Data from ClinicalTrials.gov

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