A Phase 1/1b Trial of MK-1966 in Combination with SD-101 in Subjects with Advanced Malignancies

This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the treatment of advanced malignancies. The study will include an initial Dose Evaluation phase to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following determination of the MTD/MAD, approximately 20 participants each will be enrolled in two expansion cohorts to confirm/refine the MTD/MAD.

Inclusion Criteria:
• Has a histologically- or cytologically-confirmed advanced malignancy that has progressed after standard-of-care therapy/treatments and there is no available therapy likely to convey clinical benefit
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Has a life expectancy ≥ 6 months
• Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy)
• Female and male participants of reproductive potential must agree to use adequate contraception during the course of the study through 120 days after study the last dose of study therapy
• Has ability to submit archived or fresh tumor sample during the screening period

Exclusion Criteria:
• Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
• Has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of study start
• Is expected to require any other form of antineoplastic therapy while on study
• Is on chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
• Has a history of a malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has an active infection requiring therapy
• Has active, non-infectious pneumonitis
• Has had a prior stem cell or bone marrow transplant
• Is positive for Human Immunodeficiency Virus (HIV) and/or Hepatitis B or C
• Has known psychiatric disorder that would interfere with fulfilling the requirements of the study
• Is a regular user of any illicit drugs or had a recent history of substance abuse
• Has symptomatic ascites or pleural effusion
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
• Has clinically significant heart disease that affects normal activities
• Has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days
• Has received a live vaccine within 30 days prior to first dose of study therapy
Phase I
Multiple Tumor Types
Rom Leidner, M.D.
Kim Sutcliffe
  • Oncology and Hematology Care Eastside