Clinical Trials in the UK / NCT05720117
Recruiting
Phase 1
A Study of PYX-201 in Advanced Solid Tumors
NCT05720117 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Solid TumorAdvanced Solid Tumor
Study summary
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.
Eligibility
Inclusion
1. 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 ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1/PD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Life expectancy of \>3 months, in the opinion of the Investigator.
6. Corrected QTcF \<470 msec.
7. Adequate hematologic function.
8. Adequate hepatic function.
9. Adequate renal function.
10. Adequate coagulation profile.
11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.
Exclusion
1. 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.
2. Known symptomatic brain metastases.
3. Significant cardiovascular disease within 6 months prior to start of study drug.
4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
7. Participants with NCI-CTCAE v5.0 Grade \>1 neuropathy of any etiology.
8. Prior solid organ or bone marrow progenitor cell transplantation.
9. Prior high-dose chemotherapy requiring stem cell rescue.
10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
11. Palliative radiation therapy within 14 days prior to the start of study drug.
12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
13. History of uncontrolled diabetes mellitus.
14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
17. 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 scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Primary outcome measure(s)
- Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation — Day 1 to Day 21
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol. - Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation — Up to approximately 3 years
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs. - Objective Response Rate (ORR) observed in participants in Dose Expansion — Up to approximately 2 years
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | Recruiting |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | Recruiting |
| SCRI - HealthOne Denver | Denver | Colorado | Recruiting |
| SCRI - Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | Recruiting |
| University of Chicago Medicine | Chicago | Illinois | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | Recruiting |
| NEXT Dallas | Dallas | Texas | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| NEXT San Antonio | San Antonio | Texas | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| Institut Jules Bordet | Brussels | Brussels Capital | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | Recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Edegem | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Gent | Recruiting |
| Hospital Universitari Vall d'Hebrón | Barcelona | Barcelona | Recruiting |
| START Madrid - Hospital Universitario Fundación Jiménez Díaz | Madrid | Madrid | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | Recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Madrid | Recruiting |
| Hospital Clínico Universitario de Valencia | Valencia | València | Recruiting |
| University College Hospital | London | England | Recruiting |
| The Royal Marsden Hospital | London | England | Recruiting |
| Sarah Cannon Research Institute London | London | England | Active Not Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05720117 on ClinicalTrials.gov ↗ ← All trials in the UK