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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPyxis Oncology, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PYX-201

    Drug

    Intravenous (IV) infusion.

  • pembrolizumab

    Drug

    IV infusion.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 2 interventions
Group B: Part 2: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1 to Day 21
2

Number of Participants who Experience an Adverse Event (AE)

Time frame
Up to approximately 2 years
3

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

Time frame
Up to approximately 2 years
4

Number of Participants who Experience Clinically Significant Changes in Vital Signs

Time frame
Up to approximately 2 years

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Day 1 up to approximately 2 years
2

Duration of Response (DOR)

Time frame
Day 1 up to approximately 2 years
3

Disease Control Rate (DCR)

Time frame
Day 1 up to approximately 2 years
4

Time to Response

Time frame
Day 1 up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pyxis Oncology, Inc

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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