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

NCT06795412 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: PYX-201-102KEYNOTE-G17MK-3475-G172025-521828-30-00
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 19

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; PYX-201; Pembrolizumab

Outcome Measures

Primary Outcomes (5)

• Number of Participants who Experience a Dose-Limiting Toxicity (DLT)

  Day 1 to Day 21

• Number of Participants who Experience an Adverse Event (AE)

  Up to approximately 2 years

• Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters

  Up to approximately 2 years

• Number of Participants who Experience Clinically Significant Changes in Vital Signs

  Up to approximately 2 years

• Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters

  Up to approximately 2 years

Secondary Outcomes (15)

• Objective Response Rate (ORR)

  Day 1 up to approximately 2 years

• Duration of Response (DOR)

  Day 1 up to approximately 2 years

• Disease Control Rate (DCR)

  Day 1 up to approximately 2 years

• Time to Response

  Day 1 up to approximately 2 years

• Clinical Benefit Rate (CBR)

  Day 1 up to approximately 2 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.

Drug: PYX-201; Drug: pembrolizumab

Part 2: Dose Expansion

EXPERIMENTAL

Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.

Drug: PYX-201; Drug: pembrolizumab

Interventions

PYX-201 DRUG

Intravenous (IV) infusion.

Part 1: Dose Escalation; Part 2: Dose Expansion

pembrolizumab DRUG

IV infusion.

Also known as: KEYTRUDA®

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pyxis Oncology, Inc: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (19)

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

University of Texas - M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology Houston

Houston, Texas, 77054, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Hopital Saint - Andre - CHU de Bordeaux

Bordeaux, 33075, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Hôpital de la Timone

Marseille, 13385, France

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Pyxis Oncology Clinical Trial Team

CONTACT

617-453-3596; clinicaltrials@pyxisoncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); FR (3); ES (5)