A Phase I/II, 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

Study Identifier:
PYX-201-102
CT.gov Identifier:
NCT06795412
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study 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. To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MICVO in combination with pembrolizumab The dose expansion part of the study will further explore preliminary antitumor activity of the combination

To evaluate MICVO in combination with KEYTRUDA® is part of a Clinical Trial Collaboration Agreement with Merck (known as MSD outside the US and Canada) and is currently in dose escalation across multiple doses and tumor types, including 1L/2L+ R/M HNSCC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 1. 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.
    • 2. Male or non-pregnant, non-lactating female participants age ≥18 years.
    • 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
    • 4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.
    • 5. Life expectancy of \>3 months, in the opinion of the Investigator.
    • 6. Adequate hematologic function.
    • 7. Adequate hepatic function.
    • 8. Adequate renal function.
    • 9. Adequate coagulation profile.
    • 10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.
    • The dose escalation part of the study will enroll patients with advanced 1L R/M HNSCC with PD-L1 CPS ≥ 1 and other tumor types (i.e., advanced triple negative breast cancer, HR+ and HER2- breast cancer, sarcoma, gastric, cervical cancer, and 2L+ HNSCC) that have progressed on standard therapies.
    Exclusion criteria
    • 1. Known additional malignancy that is progressing or has required active treatment within the past 2 years.
    • 2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
    • 3. Significant cardiovascular disease within 6 months prior to start of study drug.
    • 4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
    • 5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
    • 6. 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.
    • 7. Participants with active neuropathy of any grade per CTCAE v5.0 at Screening.
    • 8. History of uncontrolled diabetes mellitus.
    • 9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
    • 10. Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
    • 11. Prior solid organ or bone marrow progenitor cell transplantation.
    • 12. Prior high-dose chemotherapy requiring stem cell rescue.
    • 13. 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.
    • 14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Manuel Pedregal Trujillo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor