Clinical trial

A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

Name

831-IO-101

Description

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

Trial arms

Trial start

2022-03-31

Estimated PCD

2025-07-01

Trial end

2026-03-01

Status

Recruiting

Phase

Early phase I

Treatment

NGM831

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

Arms:

NGM831 Monotherapy Dose Escalation

NGM831 plus pembrolizumab (KEYTRUDA®)

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.

Arms:

NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

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.

Arms:

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

Size

130

Primary endpoint

Number of Patients with Dose-limiting Toxicities

Baseline up to 21 Days

Incidence of Adverse Events

Baseline up to Approximately 24 months

Eligibility criteria

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. Exclusion Criteria: * Prior treatment targeting ILT3. * Prior treatment targeting LAIR1.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

Updated at

2024-02-15

1 organization

6 products

15 indications

Organization

NGM Biopharmaceuticals

Product

NGM831

Indication

Pancreatic Cancer

Indication