PF-07225570 + Sasanlimab for Bladder Cancer

No longer recruiting at 14 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Muscle-invasive cancer, Autoimmune disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PF-07225570, both alone and in combination with another drug, sasanlimab (an experimental treatment). The goal is to assess the safety and effectiveness of these treatments for individuals with recurrent non-muscle invasive bladder cancer that hasn't spread to the muscles or beyond. The trial will be divided into parts to determine the best doses. It seeks participants with non-muscle invasive bladder cancer that recurs and who haven't had or have chosen not to have major bladder surgery. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07225570 remains under investigation to determine its safety for people, with current information based on early research. As a result, detailed reactions to the treatment are not yet available. This treatment is in the early testing stages, focusing on safety and tolerance.

For the combination of PF-07225570 with sasanlimab, studies have found that sasanlimab, when combined with other treatments, maintains a safety profile similar to known treatments. This suggests that people generally tolerate it well, though further research is needed for a clearer understanding.

Since both treatments are in the early testing phases, researchers are primarily examining safety and bodily responses. Progressing beyond these early stages typically indicates that participants have tolerated the treatment well so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for recurrent non-muscle invasive bladder cancer (NMIBC), which often involve surgical procedures and traditional chemotherapy, PF-07225570 offers a unique approach by being administered intravesically (directly into the bladder). This method targets the cancer more directly, potentially reducing systemic side effects. Additionally, the combination with sasanlimab, an anti-PD-1 antibody, may enhance the immune system's ability to fight cancer cells, offering a novel mechanism of action compared to conventional therapies. Researchers are excited about these treatments because they could offer more effective and less invasive options for patients with NMIBC.

What evidence suggests that this trial's treatments could be effective for recurrent non-muscle invasive bladder cancer?

Research has shown that PF-07225570 is a new drug being tested to treat bladder cancer that hasn't spread. This trial includes a treatment arm where participants receive PF-07225570 as monotherapy, targeting cancer cells directly in the bladder. Early studies are exploring its potential to shrink tumors. Another arm in this trial combines PF-07225570 with Sasanlimab, and this combination has shown promise in reducing the risk of cancer returning or worsening. Specifically, a study found that using Sasanlimab with other treatments significantly lowered cancer-related issues by 32%. Early results suggest that this combination could offer a new way to manage recurring non-muscle invasive bladder cancer effectively. ^{2 5 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Single agent dose escalation of PF-07225570 and combination dose escalation with an anti-PD-1 antibody

8-12 weeks

Dose Expansion

Dose expansion of PF-07225570 alone and in combination with an anti-PD-1 antibody

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• PF-07225570
• Sasanlimab

How Is the Trial Designed?

Group I: Part 2B PF-07225570 and sasanlimab Experimental Treatment 2 Interventions

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Group II: Part 2A PF-07225570 monotherapy Experimental Treatment 1 Intervention

IVe Single Agent Dose Expansion

Group III: Part 1B PF-07225570 and sasanlimab Experimental Treatment 2 Interventions

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

Group IV: Part 1A PF-07225570 monotherapy Experimental Treatment 1 Intervention

Intravesical (IVe) Single Agent Dose Escalation

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Cadonilimab, an anti PD-1 and CTLA-4 bispecific antibody, showed limited efficacy in treating previously treated metastatic non-small-cell lung cancer (NSCLC), achieving an objective response rate of only 10% in patients who were immunotherapy naïve after platinum-based chemotherapy.

The treatment was well-tolerated, with only 11.3% of patients experiencing grade 3-4 adverse events, suggesting that cadonilimab could be a viable option for second-line therapy in NSCLC, particularly for those who have not previously received immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, open-label phase Ib/II study of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) monotherapy in previously treated advanced non-small-cell lung cancer (AK104-202 study). Zhao, Y., Ma, Y., Fan, Y., et al.[2023]

Sasanlimab, an anti-PD-1 monoclonal antibody, shows efficacy in treating advanced solid tumors, with response significantly associated with baseline tumor mutational burden (TMB), PD-L1, and CD8 expression in a study involving 38 patients.

The study highlights that higher expression levels of genes related to interferon-γ and PD-1 signaling pathways correlate with better responses to sasanlimab, indicating its immunomodulatory mechanism across various tumor types and administration routes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration. Hu-Lieskovan, S., Braiteh, F., Grilley-Olson, JE., et al.[2022]

Dostarlimab showed promising antitumor activity in patients with recurrent/advanced non-small cell lung cancer (NSCLC) who had progressed after platinum-based chemotherapy, achieving an immune-related objective response rate (irORR) of 26.9% across various PD-L1 expression levels.

The treatment was generally well-tolerated, with fatigue being the most common severe adverse event (4.5%), and immune-related treatment-emergent adverse events occurring in 28.4% of patients, indicating an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. Moreno, V., Roda, D., Pikiel, J., et al.[2023]

Sasanlimab, an antibody targeting the PD-1 receptor, was well tolerated in patients with non-small-cell lung cancer (NSCLC) and urothelial carcinoma, with only 13.2% experiencing severe treatment-related side effects.

The treatment showed promising efficacy, with objective response rates of 16.4% in NSCLC and 18.4% in urothelial carcinoma, particularly in patients with high PD-L1 expression and tumor mutational burden, suggesting it may be a viable option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma. Cho, BC., Penkov, K., Bondarenko, I., et al.[2023]

In a phase 3 clinical trial involving 355 patients with advanced squamous non-small-cell lung cancer (sq-NSCLC), the combination of tislelizumab and chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone, with PFS of 7.6 months for the combination versus 5.5 months for chemotherapy alone.

The addition of tislelizumab also resulted in higher objective response rates (ORR) and longer duration of response, while maintaining a manageable safety profile, with no deaths directly attributed to tislelizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. Wang, J., Lu, S., Yu, X., et al.[2022]

Citations

1. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-significantly-improves-event

Pfizer's Sasanlimab Combination Significantly Improves ... Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or ...

2. withpower.com withpower.com/trial/phase-1-urinary-bladder-neoplasms-2-2022-780f5

PF-07225570 Alone or in Combination With an Anti-PD-1 ... Sasanlimab, a drug that targets the PD-1 receptor, has shown promise in treating non-small-cell lung cancer and urothelial carcinoma, as it is part of a class ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04165317

NCT04165317 | A Study of Sasanlimab in People With Non ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38189180/

phase III study of sasanlimab and Bacillus Calmette-Guérin ... The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is ...

5. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-press-releases/159966-pfizer-s-sasanlimab-combination-significantly-improves-event-free-survival-in-bcg-naive-high-risk-non-muscle-invasive-bladder-cancer.html

Pfizer's Sasanlimab Combination Significantly Improves ... Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or progression, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04165317

NCT04165317 | A Study of Sasanlimab in People With Non ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.

7. trial.medpath.com trial.medpath.com/clinical-trial/57012151d445e5fe/nct05259397-pf-07225570-recurrent-bladder-cancer

PF-07225570 Alone or in Combination With an Anti-PD-1 ... The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in ...

8. bcan.org bcan.org/clinicaltrials/sasanlimab-pf-06801591-in-combination-with-bacillus-calmette-guerin-bcg-in-participants-with-high-risk-non-muscle-invasive-bladder-cancer/

Sasanlimab (PF-06801591) in Combination With Bacillus ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.