Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

Launched by PYXIS ONCOLOGY, INC · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called PYX-201 combined with another drug called pembrolizumab for patients with advanced solid tumors, which are types of cancer that form in different tissues of the body. The main goal of the study is to find the best dose of PYX-201 that can be used safely alongside pembrolizumab. If you or a loved one has advanced solid tumors, including specific types of breast, head and neck, gastric, or cervical cancers, you might be eligible to participate. To qualify, participants must be at least 18 years old, have a measurable tumor, and be in reasonably good health, among other criteria.

If you join this trial, you can expect to receive close medical supervision and support throughout the study. The researchers will monitor your health and how well the treatment works, aiming to gather important information that could help improve cancer care in the future. It's important to note that this study is currently recruiting participants, and there are specific medical conditions and previous treatments that may prevent someone from joining. If you're interested, discussing this opportunity with your healthcare provider could be a good next step.

Gender

ALL

Eligibility 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 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.
• • 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.