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New treatment option for Solid Tumor
Official title A Study of PYX-201 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05720117
What this study is testing
What is PYX-201?
PYX-201 is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inclusion
- Histologically or cytologically confirmed solid tumors including locally advanced/metastatic HR+ and HER2- breast cancer (post CDK4/6 inhibitor +/-...
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
See the full eligibility criteria
- Inclusion
- Histologically or cytologically confirmed solid tumors including locally advanced/metastatic HR+ and HER2- breast cancer (post CDK4/6 inhibitor +/- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post...
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Life expectancy of \>3 months, in the opinion of the Investigator.
- Corrected QTcF \<470 msec.
- Adequate hematologic function.
- Adequate hepatic function.
- Adequate renal function.
- Adequate coagulation profile.
- Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample. Exclusion
- History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to start of study drug.
- Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
- Participants with NCI-CTCAE v5.0 Grade \>1 neuropathy of any etiology.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
- Palliative radiation therapy within 14 days prior to the start of study drug.
- Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
- History of uncontrolled diabetes mellitus.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
- Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
- Participants with a history of (noninfectious) pneumonitis/ interstitial lung disease that required steroids, has current pneumonitis/ interstitial lung disease, or evidence of active pneumonitis on screening chest CT...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Brussels, Brussels Capital, Belgium
- Edegem, Edegem, Belgium
- Ghent, Gent, Belgium
- Barcelona, Barcelona, Spain
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Denver, Colorado, United States; Sarasota, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.