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

NGM Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 1

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

Treatments: Drug: Pembrolizumab (KEYTRUDA ®); Drug: NGM438

Study type: Interventional

Funder types: Industry

Identifiers

NCT05311618

MK-3475-E20 (Other Identifier)

438-IO-101

KEYNOTE-E20 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 71 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.
• 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.

Exclusion criteria

• Prior treatment targeting LAIR1

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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71 participants in 3 patient groups

NGM438 Monotherapy Dose Escalation

Experimental group

Description:

Part 1a Single Agent Dose Escalation

Treatment:

Drug: NGM438

NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )

Experimental group

Description:

Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )

Treatment:

Drug: Pembrolizumab (KEYTRUDA ®)

Drug: NGM438

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

Experimental group

Description:

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

Treatment:

Drug: Pembrolizumab (KEYTRUDA ®)

Drug: NGM438