PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

NCT05259397 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: C46610012021-005858-28
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 4

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).

Conditions

Bladder Cancer

Keywords

Recurrent Non-Muscle Invasive Bladder Cancer (NMIBC); Urothelial cancer; Toll-like receptor 7 (TLR7); Toll-like receptor 8 (TLR8)

Outcome Measures

Primary Outcomes (4)

• Number of participants with Dose limiting toxicities

  Baseline up to 28 days

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

  Baseline up to approximately 24 months

• Number of Participants with AEs according to Seriousness

  Baseline up to approximately 24 months

• Number of Participants with AEs according to Relationship

  Baseline up to approximately 24 months

Secondary Outcomes (17)

• 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

• 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

• 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

• 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 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

Study Arms (4)

Part 1A PF-07225570 monotherapy

EXPERIMENTAL

Intravesical (IVe) Single Agent Dose Escalation

Drug: PF-07225570

Part 1B PF-07225570 and sasanlimab

EXPERIMENTAL

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

Drug: PF-07225570; Drug: sasanlimab

Part 2A PF-07225570 monotherapy

EXPERIMENTAL

IVe Single Agent Dose Expansion

Drug: PF-07225570

Part 2B PF-07225570 and sasanlimab

EXPERIMENTAL

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Drug: PF-07225570; Drug: sasanlimab

Interventions

PF-07225570 DRUG

PF-07225570 given IVe in a 28-day cycle (as induction and maintenance regimen). Multiple dose levels will be evaluated.

Part 1A PF-07225570 monotherapy; Part 1B PF-07225570 and sasanlimab; Part 2A PF-07225570 monotherapy; Part 2B PF-07225570 and sasanlimab

sasanlimab DRUG

Sasanlimab will be administered SQ on day 1 of each 28 day cycle.

Also known as: anti-PD-1 (programmed cell death protein-1) antibody

Part 1B PF-07225570 and sasanlimab; Part 2B PF-07225570 and sasanlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States

Location

CUMC Research Pharmacy

New York, New York, 10032, United States

Location

Szpital Specjalistyczny im. Sw. Rodziny SPZOZ

Warsaw, 02-544, Poland

Location

Medical Concierge Centrum Medyczne

Warsaw, 02-798, Poland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Antibodies

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 28, 2022
• Study Start: March 24, 2022
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); US (2)