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Recruiting NCT06795412

Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumors

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, pembrolizumab.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. 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, France, Spain
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 Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

Overview

The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.

Interventions

  • Drug PYX-201
    Intravenous (IV) infusion.
  • Drug pembrolizumab
    IV infusion.

Primary outcome measures

  • Number of Participants who Experience a Dose-Limiting Toxicity (DLT) [Time frame: Day 1 to Day 21]
  • Number of Participants who Experience an Adverse Event (AE) [Time frame: Up to approximately 2 years]
  • Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters [Time frame: Up to approximately 2 years]
  • Number of Participants who Experience Clinically Significant Changes in Vital Signs [Time frame: Up to approximately 2 years]
  • Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) [Time frame: Day 1 up to approximately 2 years]
  • Duration of Response (DOR) [Time frame: Day 1 up to approximately 2 years]
  • Disease Control Rate (DCR) [Time frame: Day 1 up to approximately 2 years]
  • Time to Response [Time frame: Day 1 up to approximately 2 years]
  • Clinical Benefit Rate (CBR) [Time frame: Day 1 up to approximately 2 years]
  • Maximum Observed Concentration (Cmax) of PYX-201 [Time frame: Day 1 up to approximately 2 years]
  • Time to Maximum Concentration (Tmax) of PYX-201 [Time frame: Day 1 up to approximately 2 years]
  • Clearance (CL) of PYX-201 [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 [Time frame: Day 1 up to approximately 2 years]
  • Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 [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 [Time frame: Day 1 up to approximately 2 years]
  • Half-Life (t½) for Antibody-drug Conjugate (ADC) [Time frame: Day 1 up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.
  • Male or non-pregnant, non-lactating female participants age ≥18 years.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
  • Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  • Life expectancy of >3 months, in the opinion of the Investigator.
  • 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 criteria

  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Have any active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • 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 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.
  • Participants with Grade >1 neuropathy of any grade per CTCAE v5.0 and/or receiving treatment for neuropathy at Screening.
  • History of uncontrolled diabetes mellitus.
  • Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
  • Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Prior solid organ or bone marrow progenitor cell transplantation.
  • Prior high-dose chemotherapy requiring stem cell rescue.
  • Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.
  • Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.

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
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • University of California San Diego — San Diego
  • Sarcoma Oncology Center — Santa Monica
  • Moffitt Cancer Center — Tampa
  • University of Chicago — Chicago
  • Massachusetts General Hospital — Boston
  • Dana-Farber Cancer Institute — Boston
  • University of Pennsylvania — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh
  • … and 3 more centers
Spain · 5 centers
  • Hospital Universitario Vall d'Hebron — Barcelona
  • Hospital Universitario Ramón y Cajal — Madrid
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Clínico Universitario de Valencia — Valencia
France · 3 centers
  • Hopital Saint - Andre - CHU de Bordeaux — Bordeaux
  • Centre Léon Bérard — Lyon
  • Hôpital de la Timone — Marseille

Identifiers

NCT: NCT06795412 · PYX-201-102 · KEYNOTE-G17 · MK-3475-G17 · 2025-521828-30-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗