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

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Bladder Cancer

Treatments: Drug: PF-07225570; Drug: sasanlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05259397

2021-005858-28 (EudraCT Number)

C4661001

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Part 1A PF-07225570 monotherapy

Experimental group

Description:

Intravesical (IVe) Single Agent Dose Escalation

Treatment:

Drug: PF-07225570

Part 1B PF-07225570 and sasanlimab

Experimental group

Description:

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

Treatment:

Drug: sasanlimab

Drug: PF-07225570

Part 2A PF-07225570 monotherapy

Experimental group

Description:

IVe Single Agent Dose Expansion

Treatment:

Drug: PF-07225570

Part 2B PF-07225570 and sasanlimab

Experimental group

Description:

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Treatment:

Drug: sasanlimab

Drug: PF-07225570