A Study of IMC-RON8 in Advanced Solid Tumors
Condition: Cancer
Intervention: IMC-RON8; IMC-RON8; IMC-RON8; IMC-RON8; IMC-RON8; IMC-RON8; IMC-RON8; IMC-RON8
Intervention description: 5 milligrams per kilogram (mg/kg) intravenously (IV)
Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
Cohort 1; 10 mg/kg IV
Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
Cohort 2; 15 mg/kg IV
Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
Cohort 3; 15 mg/kg IV
Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
Cohort 4; 20 mg/kg IV
Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
Cohort 5; 25 or 30 mg/kg IV
Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
Cohort 6; 30, 35, or 40 mg/kg IV
Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
Cohort 7; 20 or 25 mg/kg IV
Once every week for each 4-week treatment cycle, for a total of four doses per cycle.
Cohort 8
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tumors; Macrophage stimulating 1 receptor, human; RON protein; RON receptor protein tyrosine kinase

Summary:

      A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants
      with solid tumors. Participants can either be dosed once a week, or once every other week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has histologically-confirmed advanced primary or recurrent solid
             tumors that have not responded to standard therapy or for which no standard therapy is
             available

          -  The participant has measurable or non-measurable disease

          -  The participant has not received major surgery, prior chemotherapy, prior treatment
             with an investigational agent or device, or prior radiation therapy within 28 days
             prior to the first dose of study therapy

          -  The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS)
             score of 0-2

          -  The participant has adequate hematologic function

          -  The participant has adequate renal function as defined by serum creatinine ≤1.5 times
             the institutional upper limit of normal (ULN)

          -  The participant has a life expectancy >3 months

        Exclusion Criteria:

          -  The participant has received chemotherapy or therapeutic radiation therapy within 28
             days prior to the first dose of study therapy

          -  The participant has ongoing toxicities of >Grade 1 associated with any prior treatment

          -  The participant has a known sensitivity to monoclonal antibodies or other therapeutic
             agents, or to agents of similar biologic composition as IMC-RON8

          -  The participant has received treatment with any monoclonal antibodies within 6 weeks
             prior to first dose of study therapy

          -  The participant has received treatment with agents specifically targeting the RON
             ligand or receptor within 6 weeks prior to first dose of study therapy

          -  The participant has undergone a major surgical procedure, open biopsy, or experienced
             a significant traumatic injury within 28 days prior to the first dose of study therapy

          -  The participant has an ongoing or active infection, symptomatic congestive heart
             failure, unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial
             fibrillation is permitted), psychiatric illness/social situations, active bleeding, or
             any other serious uncontrolled medical disorders in the opinion of the investigator

          -  The participant has known or suspected brain or leptomeningeal metastases
             (participants with a history of brain metastases must have received definitive surgery
             or radiotherapy, be clinically stable, and may not be taking steroids; participants
             receiving anticonvulsants are eligible)

          -  The participant has a serious or nonhealing active wound, ulcer, or bone fracture

          -  The participant is currently using or has received a thrombolytic agent within 28 days
             prior to first dose of study therapy

          -  The participant is receiving full-dose warfarin (participants receiving low-dose
             warfarin to maintain the patency of permanent, indwelling intravenous catheters are
             eligible if the international normalized ratio is <1.5)

          -  The participant is receiving intravenous heparin