UPCC 13325: 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 Phase 1/2 Study of PYX-201 in Combination with Pembrolizumab in Advanced Solid Tumors

Investigational Study on the Safety and Dosage of a Medication Combination for Advanced Cancers

Enrolling By Invitation
18 years or above
All
Phase 1/2
220 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Solid Tumors
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the safety, tolerability, and effectiveness of an investigational medication combined with pembrolizumab in individuals with advanced solid tumors. The purpose of this study is to identify the best doses for future research and to understand how the body processes and responds to the treatment.

Participants will receive the investigational medication along with pembrolizumab, a treatment that helps the immune system fight cancer. The study includes several procedures such as tumor biopsies, blood tests, and imaging to monitor how the treatment affects the body and the cancer.

  • Who can participate: Adults aged 18 and older with confirmed advanced solid tumors, such as head and neck cancer or breast cancer, may be eligible. Participants must have a good performance status and adequate organ function.
  • Study details: Participants will receive the investigational medication in combination with pembrolizumab. They must undergo regular assessments, including tumor biopsies and imaging, to evaluate the treatment's effects.
Updated on 04 May 2026. Study ID: 25-1840
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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