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Recruiting NCT05720117

A Study of PYX-201 in Advanced Solid Tumors

Phase I Interventional Solid Tumor Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PYX-201.
Who it may be relevant to
Registry conditions: Solid Tumor, Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

Overview

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.

Interventions

  • Drug PYX-201
    Antibody-Drug Conjugate

Primary outcome measures

  • Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation [Time frame: Day 1 to Day 21]
  • Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation [Time frame: Up to approximately 3 years]
  • Objective Response Rate (ORR) observed in participants in Dose Expansion [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
  • Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion [Time frame: Day 1 up to approximately 2 years]
  • Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion [Time frame: Day 1 up to approximately 2 years]
  • Clearance (CL) of PYX-201 in Dose Escalation [Time frame: Day 1 up to approximately 2 years]
  • Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation [Time frame: Day 1 up to approximately 2 years]
  • Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation [Time frame: Day 1 up to approximately 2 years]
  • Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation [Time frame: Day 1 up to approximately 2 years]
  • Half-life (t½) of PYX-201 in Dose Escalation [Time frame: Day 1 up to approximately 2 years]
  • Objective Response Rate (ORR) observed in participants in Dose Escalation [Time frame: Up to approximately 3 years]
  • Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion [Time frame: Up to approximately 3 years]
  • Progression-free Survival (PFS) observed in participants in Dose Escalation [Time frame: Up to approximately 3 years]
  • Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion [Time frame: Up to approximately 3 years]
  • Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion [Time frame: Up to approximately 3 years]

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 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).
  • 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 scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • HonorHealth Research Institute — Scottsdale
  • Ronald Reagan UCLA Medical Center — Los Angeles
  • SCRI - HealthOne Denver — Denver
  • SCRI - Florida Cancer Specialists — Sarasota
  • Winship Cancer Institute, Emory University — Atlanta
  • University of Chicago Medicine — Chicago
  • Massachusetts General Hospital — Boston
  • Dana-Farber Cancer Institute — Boston
  • … and 9 more centers
Spain · 5 centers
  • Hospital Universitari Vall d'Hebrón — Barcelona
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Universitario HM Sanchinarro — Madrid
  • Hospital Clínico Universitario de Valencia — Valencia
Belgium · 4 centers
  • Institut Jules Bordet — Brussels
  • Cliniques Universitaires Saint-Luc — Brussels
  • Universitair Ziekenhuis Antwerpen — Edegem
  • Universitair Ziekenhuis Gent — Ghent
United Kingdom · 3 centers
  • University College Hospital — London
  • The Royal Marsden Hospital — London
  • Sarah Cannon Research Institute London — London

Identifiers

NCT: NCT05720117 · PYX-201-101 · 2023-509687-14-00 · 2022-002284-30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗