Clinical Trials/NCT05259397

NCT05259397

Withdrawn

Phase 1

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER

Pfizer4 sites in 2 countriesMarch 24, 2022

ConditionsBladder Cancer

InterventionsPF-07225570 sasanlimab

DrugsPF-07225570 sasanlimab

Overview

Phase: Phase 1
Intervention: PF-07225570
Conditions: Bladder Cancer
Sponsor: Pfizer
Locations: 4
Primary Endpoint: Number of Participants with AEs according to Relationship
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent non-muscle invasive bladder cancer. This study consists of 2 parts, single agent dose escalation (Part 1A), dose finding of PF-07225570 in combination with anti-PD-1 antibody (Part 1B) and dose expansion (Part 2).

Registry

clinicaltrials.gov

Start Date

March 24, 2022

End Date

September 19, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histological confirmed and documented diagnosis of non-muscle invasive urothelial carcinoma
•Participants with recurrent non-muscle invasive bladder cancer (intermediate risk or high risk)
•Ineligible for or elected not to undergo radical cystectomy
•No evidence of upper tract urothelial cancer or cancer within the prostatic urethra as documented by imaging studies performed within 6 months of enrollment
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•Adequate bone marrow, renal and liver function

Exclusion Criteria

•Evidence of muscle-invasive, locally advanced or metastatic urothelial carcinoma or concurrent extravesical, non-muscle invasive urothelial carcinoma
•Macroscopic hematuria, traumatic catheterization or active urinary tract infection
•Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
•Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness

Arms & Interventions

Part 1A PF-07225570 monotherapy

Intravesical (IVe) Single Agent Dose Escalation

Intervention: PF-07225570

Part 1B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation

Intervention: PF-07225570

Part 1B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation

Intervention: sasanlimab

Part 2A PF-07225570 monotherapy

IVe Single Agent Dose Expansion

Intervention: PF-07225570

Part 2B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Intervention: PF-07225570

Part 2B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Intervention: sasanlimab

Outcomes

Primary Outcomes

Number of Participants with AEs according to Relationship

Time Frame: Baseline up to approximately 24 months

Number of participants with Dose limiting toxicities

Time Frame: Baseline up to 28 days

Number of Participants with Adverse Events (AEs) according to Severity

Time Frame: Baseline up to approximately 24 months

Number of Participants with AEs according to Seriousness

Time Frame: Baseline up to approximately 24 months

Secondary Outcomes

Urine PF-07225570 concentration after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours, and 4 - 6 hours post-instillation on Cycle 1 Day 1)
Durability of complete responses (CRs) as measured from time of documented CR to time of high-grade tumor recurrence, disease progression, or death (whichever occurs first) in participants who achieved a CR(Baseline up to 24 months)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
Concentration from maximum to steady state (Cmax,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
Incidence of Radical Cystectomy(Baseline up to 24 months)
Serum sasanlimab concentrations(Pre-dose (within 6 hours) before each administration)
For participants with high-grade Ta/ T1 disease only, Proportion of participants without high-grade-recurrence at each assessment visit.(Baseline up to 24 months)
Area under the curve from specified time to steady state (AUCτ,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
Progression-Free Survival(Baseline up to 24 months)
Proportion of participants with carcinoma in situ (CIS) achieving complete response at any time after first dose of PF 07225570(Baseline up to 24 months)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
Urine PF-07225570 concentration after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours and 2 - 4 hours post-instillation.)
Incidence and titers of neutralizing antibodies (NAb) against sasanlimab(Pre-dose (within 6 hours) before each administration)
Maximum Observed Plasma Concentration (Cmax) of PF-7225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
Time from maximum concentration to steady state (Tmax,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
Overall survival(Baseline up to 3 years)
Incidence and titers of anti-drug antibodies (ADA) against sasanlimab(Pre-dose (within 6 hours) before each administration)