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
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
Treatments tested in this trial
- PYX-201
- pembrolizumab
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pyxis Oncology, Inc
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov