Study of PYX-201 in Solid Tumors
Purpose
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.
Conditions
- Solid Tumor
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PYX-201 Dose Escalation |
Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. Intra-participant dose escalation may be considered for participants who have adequately tolerated therapy. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Pyxis Oncology, Inc