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A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Description

Brief Summary
An open-label Phase 2 study of PT2977 in combination with cabozantinib in patients with advanced ccRCC.


Detailed Description
This is an open-label Phase 2 study which will evaluate the efficacy and safety of PT2977 in combination with cabozantinib in patients with advanced ccRCC. PT2977 will be administered orally and cabozantinib will be administered orally once daily.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Has the ability to understand and willingness to sign a written informed consent form before the performance of any study-specific procedures
  • 18 years of age or older
  • Has locally advanced or metastatic RCC with predominantly clear cell subtype
  • Has at least one measurable lesion as defined by RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Has adequate organ function defined as follows:
  • Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
  • Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)
  • Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease
  • Cohort 1: Patients must not have received prior systemic therapy for advanced or metastatic ccRCC
  • Cohort 2: Patients must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC Exclusion Criteria:
  • Has received prior treatment with PT2977 or other HIF2α inhibitors
  • Has received prior treatment with cabozantinib
  • Has had radiation therapy for bone metastases within two weeks of starting study drug
  • Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression
  • Has failed to recover from the reversible effects of prior anticancer therapy
  • Has uncontrolled or poorly controlled hypertension
  • Is receiving anticoagulant therapy
  • Has had any major cardiovascular event within 6 months prior to study drug administration
  • Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
  • Has had major surgery within 3 months before first study drug administration
  • Has an active infection requiring systemic treatment
  • Is participating in another therapeutic clinical trial

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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