A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: PF-06647020 Q3W; fluconazole; PF-06647020 Q2W; PF-06647020 combined with Avelumab
Intervention description: Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.; combination drug used for drug-drug interaction sub-study; Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.; Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
Intervention MeSH terms: Fluconazole; Avelumab; Cofetuzumab pelidotin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADC; PF-06647020; solid tumors; tumors; neoplasm metastasis; TNBC; triple negative breast cancer; NSCLC; non small cell lung cancer; advanced metastatic breast cancer; ovarian cancer; OVCA

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients
      with advanced solid tumors in order to determine the maximum tolerated dose and select the
      recommended Phase 2 dose.
    

Eligibility criteria:

        Q2W Inclusion Criteria:

          -  Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior
             lines, or recurrent advanced NSCLC having received 3 or fewer prior lines

          -  Performance Status of 0, 1, or 2

          -  Adequate bone marrow, kidney, and liver function

        Q2W Exclusion Criteria:

          -  OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
             mullerian tumors, unresolved bowel obstruction

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

          -  Active and clinically significant bacterial, fungal, or viral infection

        Q3W Inclusion Criteria:

          -  Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy
             or for whom no standard therapy is available

          -  Performance Status of 0 or 1

          -  Adequate bone marrow, kidney, and liver function

          -  Part 2 includes ovarian cancer, target expressing triple negative breast cancer and
             non small cell lung cancer patients

        Q3W Exclusion Criteria:

          -  OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
             mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease,
             unresolved bowel obstruction

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

          -  Active and clinically significant bacterial, fungal, or viral infection