RecruitingAdvanced Solid Tumors
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this 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.
Sponsor: Pyxis Oncology, Inc
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
San Diego · Santa Monica
Florida
Tampa
Illinois
Chicago
Massachusetts
Boston
Pennsylvania
Philadelphia · Pittsburgh
Texas
Houston
Virginia
Fairfax
Source: ClinicalTrials.gov · NCT06795412 · last updated 2026-05-04