CompletedPhase 1 / Phase 2NCT02713529

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer

A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.

Checked against the public recordLast updated Jan 20, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations15
SponsorAmMax Bio, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
AmMax Bio, Inc.
Interventions being studied
Biological: AMG820 and pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment. * Measurable disease per RECIST 1.1 guidelines. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests. * Availability of recent tumor tissue within 3 months prior to enrollment, when feasible. Exclusion Criteria: * Has known active central nervous system metastases and/or carcinomatous meningitis. * History of other malignancy with the past 2 years with some exceptions * Evidence of active non-infectious pneumonitis/interstitial lung disease * Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years. * Evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection. * Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b). * Evidence of active infection within 2 weeks prior to first dose of study treatment. * Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment * Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment * Received live vaccine within 28 days prior to enrollment * Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better. * Positive for human immunodeficiency virus (HIV), Hepatitis B or C * Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAtlanta, Georgia
  • Research SiteBoston, Massachusetts
  • Research SiteBoston, Massachusetts
  • Research SiteGrand Rapids, Michigan
  • Research SiteNew York, New York
  • Research SitePhiladelphia, Pennsylvania
  • Research SiteGreenville, South Carolina
  • South Texas Accelerated Research TherapeuticsSan Antonio, Texas
  • Research SiteCamperdown, New South Wales
  • Research SiteParkville, Victoria
  • Research SiteWilrijk
  • Princess Margaret Cancer CentreToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2023. Always confirm current availability with the study team.

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