Clinical Trial 23647

• Overview

  Study Title:

  A Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

  Summary:

  The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.

  Objective:

  Primary Objective: To determine the RP2D(s) and MTD of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors Secondary Objectives: To evaluate the preliminary efficacy of treatment with PYX-201 in combination with pembrolizumab. To characterize the PK profile of PYX-201 in combination with pembrolizumab. To evaluate the immunogenicity of PYX-201 as measured by the incidence of ADAs in participants treated with PYX-201 in combination with pembrolizumab.

• Treatments

  Therapies:

  anti-EDB+FN-mAb-vc0101 ADC; humanized IgG4 anti-PD-1 mAb

  Medications:

  PYX-201 (); Pembrolizumab (Keytruda)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.
  • Male or non-pregnant, non-lactating female participants age ≥18 years.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
  • Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.
  • Life expectancy of >3 months, in the opinion of the Investigator.
  • Adequate hematologic function.
  • Adequate hepatic function.
  • Adequate renal function.
  • Adequate coagulation profile.
  • Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Significant cardiovascular disease within 6 months prior to start of study drug.
  • Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
  • Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  • Failure to recover to Baseline severity or National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.
  • Participants with active neuropathy of any grade per CTCAE v5.0 at Screening.
  • History of uncontrolled diabetes mellitus.
  • Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
  • Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Prior solid organ or bone marrow progenitor cell transplantation.
  • Prior high-dose chemotherapy requiring stem cell rescue.
  • Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.
  • Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.

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