NCT06795412 · Pyxis Oncology, Inc
Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
PYX-201
Intravenous (IV) infusion.
DRUG
pembrolizumab
IV infusion.
Primary outcome measures
Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters
Time frame: Up to approximately 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. 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. Exclus
Where
- San Diego, California
- Santa Monica, California
- Tampa, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Houston, Texas
- Fairfax, Virginia
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations