A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Or Metastatic Solid Tumors
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    In order to participate in this study the following criteria must be met:
    1. Adequate bone marrow function, including: - ANC =1500/µL -Platelet count =100×10³/µL - Hemoglobin =9.0 g/dL. Limited transfusion to reach this value is allowed after discussion with the Sponsor’s Medical Monitor. There should not be a chronic need for transfusion in the recent past (approximately 3 months).
    2. Adequate liver function, including: - Total bilirubin =1.5×ULN (except patients with Gilbert syndrome who must have total bilirubin <3.0 mg/dL) - AST =2.5×ULN (if patient has known liver metastases, then =5×ULN) - ALT =2.5×ULN (if patient has known liver metastases, then =5×ULN)

You may not be eligible for this study if the following are true:

  • You will not be able to participate in this study if you have had:
    1. History of prior malignancy other than the cancer under treatment in this study, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease-free for at least 3 years.
    2. Active brain or leptomeningeal metastasis. Patients with known brain metastases are eligible if they have been treated and an MRI shows no evidence of progression for at least 8 weeks after treatment is completed and within 3 weeks prior to first dose of study drug. Patients are not eligible if they require high dose of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
    3. Treatment with anti-neoplastic therapy (including but not limited to cytotoxic chemotherapy, major surgery, radiation, biologic agents, and investigational agents) within 28 days or <5×elimination half-life, whichever is earlier, before the first dose of study drug.

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