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

NGM Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Colorectal Carcinoma; Breast Cancer; Melanoma; Esophageal Cancer; Endocervical Cancer; Cholangiocarcinoma; Ovarian Cancer; Bladder Urothelial Cancer; Gastric Cancer; Squamous Cell Carcinoma of Head and Neck; Non-small Cell Lung Cancer; Mesothelioma; Renal Cell Carcinoma; Prostate Cancer; Cervical Cancer; Pancreatic Cancer

Treatments: Drug: NGM831; Drug: NGM831 plus pembrolizumab (KEYTRUDA®); Drug: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05215574

KEYNOTE-E13 (Other Identifier)

831-IO-101

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

NGM831 Monotherapy Dose Escalation

Experimental group

Description:

Part 1a Single Agent Dose Escalation

Treatment:

Drug: NGM831

NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)

Experimental group

Description:

Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

Treatment:

Drug: NGM831 plus pembrolizumab (KEYTRUDA®)

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

Experimental group

Description:

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

Treatment:

Drug: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)