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NCT06795412 | RECRUITING | Advanced Solid Tumours

Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Sponsor:

Pyxis Oncology, Inc

Brief 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.

Condition or disease

Advanced Solid Tumours

Intervention/treatment

PYX-201

pembrolizumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 220 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2025-04-15
Estimated Primary Completion Date : 2027-12-06
Estimated Study Completion Date : 2027-12-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 Tumors (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.
    • Exclusion Criteria
  • 1. Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • 2. Have any 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 Grade \>1 neuropathy of any grade per CTCAE v5.0 and/or receiving treatment for neuropathy 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.
    • Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

    Location Details

    NCT06795412

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    University of California San Diego

    San Diego, California, United States, 92093

    RECRUITING

    United States, California

    Sarcoma Oncology Center

    Santa Monica, California, United States, 90403

    RECRUITING

    United States, Florida

    Moffitt Cancer Center

    Tampa, florida, United States, 33612

    RECRUITING

    United States, Massachusetts

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    RECRUITING

    United States, Massachusetts

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    RECRUITING

    United States, Pennsylvania

    University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104

    RECRUITING

    United States, Pennsylvania

    University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States, 15232

    RECRUITING

    United States, Texas

    University of Texas - M.D. Anderson Cancer Center

    Houston, Texas, United States, 77030

    RECRUITING

    United States, Texas

    NEXT Oncology Houston

    Houston, Texas, United States, 77054

    RECRUITING

    United States, Virginia

    NEXT Virginia

    Fairfax, Virginia, United States, 22031

    RECRUITING

    Spain, Barcelona

    Vall d'Hebron University Hospital

    Barcelona, Barcelona, Spain, 08035

    RECRUITING

    Spain, Madrid

    Ramón y Cajal University Hospital

    Madrid, Madrid, Spain, 28034

    RECRUITING

    Spain, Madrid

    START Madrid - Jiménez Díaz Foundation University Hospital

    Madrid, Madrid, Spain, 28040

    RECRUITING

    Spain, Madrid

    12 de Octubre University Hospital

    Madrid, Madrid, Spain, 28041

    RECRUITING

    Spain, Valencia

    Valencia University Clinical Hospital

    Valencia, Valencia, Spain, 46010