A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mereo BioPharma
• Collaborator: ICON Clinical Research
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Histological or cytological diagnosis of a relevant tumor type as per the study protocol and not candidates for curative surgery or radiation therapy

• Available tumor tissue (archival or newly obtained core or excisional biopsy)

• Adequate hematologic and end organ function as measured by laboratory screening panel in the 14 days prior to treatment

• Life expectancy greater than 12 weeks.

• ECOG performance status of 0 to 1

• Adequate contraception for women of childbearing potential

• Pre-specified wash-out of prior anti-PD1/PDL-1 therapy

Exclusion Criteria:

• Concurrent active malignancy

• Major surgery within 4 weeks of treatment

• Subjects with active, known or suspected autoimmune diseases

• Prior treatment with CD137 agonists, anti-CTLA-4 and anti-TIGIT antibodies

• History of any Grade 3 or 4 immune-related AE toxicity from prior immunotherapy that resulted in treatment discontinuation

• History of immune-related adverse events that lead to discontinuation of anti-PD-1 or PDL-1 therapy

• Active infections of HIV, hepatitis B, hepatitis C

• Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the subject associated with participation in the study

• Pregnancy in female subjects