NCT06795412 Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
| NCT ID | NCT06795412 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Pyxis Oncology, Inc |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2027-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2025-04-15 with a primary completion date of 2027-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06795412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06795412 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06795412 currently recruiting?
Yes, NCT06795412 is actively recruiting participants. Contact the research team at clinicaltrials@pyxisoncology.com for enrollment information.
Where is the NCT06795412 trial being conducted?
This trial is being conducted at San Diego, United States, Santa Monica, United States, Tampa, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06795412 clinical trial?
NCT06795412 is sponsored by Pyxis Oncology, Inc. The trial plans to enroll 220 participants.