For Healthcare Professionals

Study of PYX-201 in Solid Tumors

clipboard-pencil

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Male or non-pregnant, non-lactating female participants age ≥18 years.
  2. Histologically or cytologically confirmed solid tumors (see details below):

  1. 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.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  3. Measurable disease according to RECIST Version 1.1.
  4. Life expectancy of >3 months, in the opinion of the Investigator.
  5. Adequate hematologic, liver and renal function.
  6. Available pre-treatment tumor biopsy.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. History of or concurrent invasive malignancy.
  2. Brain metasteses that are untreated or require current therapy.
  3. Significant cardiovascular disease.
  4. Ongoing active infection requiring systemic anti-infective therapy.
  5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  6. Prior solid organ or bone marrow transplantation.
  7. Previously received EDB+FN targeting treatments at any time prior to the start of PYX-201 treatment.
  8. Grade >1 neuropathy.
  9. History of uncontrolled diabetes mellitus.
  10. Participants with corneal epithelial disease.

pin location

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.
Phone iconCall (339) 545 8252Email iconEmail Study Center

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?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.