Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

NGM Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

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

Treatments: Drug: NGM707 plus pembrolizumab (KEYTRUDA®); Drug: NGM707

Study type: Interventional

Funder types: Industry

Identifiers

NCT04913337

707-IO-101

MK-3475-D25 (Other Identifier)

KEYNOTE-D25 (Other Identifier)

Details and patient eligibility

About

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Enrollment: 179 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, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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179 participants in 8 patient groups

NGM707 Monotherapy Dose Escalation

Experimental group

Description:

Part 1a Single Agent Dose Escalation

Treatment:

Drug: NGM707

Drug: NGM707

Drug: NGM707

Drug: NGM707

NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®)

Experimental group

Description:

Part 1b NGM707 plus pembrolizumab (KEYTRUDA®)

Treatment:

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm A

Experimental group

Description:

NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC

Treatment:

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm B

Experimental group

Description:

NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC

Treatment:

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm C

Experimental group

Description:

NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN

Treatment:

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Monotherapy Dose Expansion Arm D

Experimental group

Description:

NGM707 in RCC

Treatment:

Drug: NGM707

Drug: NGM707

Drug: NGM707

Drug: NGM707

NGM707 Monotherapy Dose Expansion Arm E

Experimental group

Description:

NGM707 in CRC

Treatment:

Drug: NGM707

Drug: NGM707

Drug: NGM707

Drug: NGM707

NGM707 Monotherapy Dose Expansion Arm F

Experimental group

Description:

NGM707 in Ovarian

Treatment:

Drug: NGM707

Drug: NGM707

Drug: NGM707

Drug: NGM707