Study of PYX-201 in Solid Tumors
About the study
The primary objective of this study is to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Histologically or cytologically confirmed solid tumors (see details below):
- For the dose escalation, the following solid tumors are allowed in participants who have developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the Investigator), which include non-small cell lung cancer (NSCLC), locally advanced/metastatic breast cancer including hormone receptor positive (HR+) and negative (HR-) breast cancer, human epidermal growth factor receptor 2 negative (HER2-) and positive (HER2+) breast cancer, triple negative breast cancer (TNBC) head and neck squamous cell carcinomas (HNSCC), ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS), hepatocellular carcinoma (HCC), and kidney cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Measurable disease according to RECIST Version 1.1.
- Life expectancy of >3 months, in the opinion of the Investigator.
- Adequate hematologic, liver and renal function.
- Available pre-treatment tumor biopsy.
EXCLUSION CRITERIA
Exclusion Criteria:
- History of or concurrent invasive malignancy.
- Brain metasteses that are untreated or require current therapy.
- Significant cardiovascular disease.
- Ongoing active infection requiring systemic anti-infective therapy.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Prior solid organ or bone marrow transplantation.
- Previously received EDB+FN targeting treatments at any time prior to the start of PYX-201 treatment.
- Grade >1 neuropathy.
- History of uncontrolled diabetes mellitus.
- Participants with corneal epithelial disease.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor,Advanced Solid Tumor
Age
18+
Phase
PHASE1
Participants Needed
80
Est. Completion Date
Jul 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Pyxis Oncology, Inc
ClinicalTrials.gov NCT Identifier
NCT05720117
Study Number
PYX-201-101
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?