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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PYX-201
DrugAntibody-Drug Conjugate
Treatment groups
330 Participants
are divided into 5 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose Expansion Cohort A (HNSCC)Experimental treatment 1 intervention
Group C: Dose Expansion Cohort B (TNBC)Experimental treatment 1 intervention
Group D: Dose Expansion Cohort C (HR+ HER2- BC)Experimental treatment 1 intervention
Group E: Dose Expansion Cohort D (Other Solid Tumor Types)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
Time frame
Day 1 to Day 212
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Time frame
Up to approximately 3 years3
Objective Response Rate (ORR) observed in participants in Dose Expansion
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Time frame
Day 1 up to approximately 2 years2
Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Time frame
Day 1 up to approximately 2 years3
Clearance (CL) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Time frame
Day 1 up to approximately 2 years4
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Time frame
Day 1 up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov