Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Male or non-pregnant, non-lactating female participants age ≥18 years.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Measurable disease according to RECIST Version 1.1.
5. Life expectancy of >3 months, in the opinion of the Investigator.
6. Adequate hematologic, liver and renal function.
7. Available pre-treatment tumor biopsy.
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.
