Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumours
• Interventions: Drug: PYX-201; Drug: pembrolizumab

• Registration Number: NCT06795412
• Lead Sponsor: Pyxis Oncology, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Study Start: 2025-03-31
• Primary Completion: 2027-12-06
• Study Completion: 2027-12-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Dose Escalation	PYX-201	Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.
Part 1: Dose Escalation	pembrolizumab	Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.
Part 2: Dose Expansion	PYX-201	Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.
Part 2: Dose Expansion	pembrolizumab	Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.

Primary Outcome Measures

Name	Time	Method
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters	Up to approximately 2 years
Number of Participants who Experience an Adverse Event (AE)	Up to approximately 2 years
Number of Participants who Experience a Dose-Limiting Toxicity (DLT)	Day 1 to Day 21
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 Outcome Measures

Name	Time	Method
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
Maximum Observed Concentration (Cmax) of PYX-201	Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201	Day 1 up to approximately 2 years
Clearance (CL) of PYX-201	Day 1 up to approximately 2 years
Incidence of Anti-PYX-201 Antibodies	Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201	Day 1 up to approximately 2 years
Half-Life (t½) for Antibody-drug Conjugate (ADC)	Day 1 up to approximately 2 years
Half-Life (t½) for Free Payload	Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201	Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201	Day 1 up to approximately 2 years
Half-Life (t½) for Total Antibody (tAb)	Day 1 up to approximately 2 years

Trial Locations

Locations (1)

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States