A Study of PYX-201 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPyxis Oncology, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- PYX-201
Treatment groups
330 Participants
are divided into 5 treatment groupsLocations
29Belgium
Cliniques Universitaires Saint-Luc1200, BrusselsBrussels Capital, Belgium
Institut Jules Bordet1070, BrusselsBrussels Capital, Belgium
Universitair Ziekenhuis Antwerpen2650, EdegemEdegem, Belgium
Universitair Ziekenhuis Gent9000, GhentGent, Belgium
Sponsors and collaborators
Pyxis Oncology, Inc
Lead sponsor
Source ClinicalTrials.gov