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Bladder CancerPhase 1NCT05259397

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

A Phase 1 study testing PF-07225570 and sasanlimab in people with Bladder Cancer, run by Pfizer at 4 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
PF-07225570 and sasanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesin 2 countries
Study dates
24 Mar 2022to 19 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

  • CUMC Research Pharmacy

    New York, New York, 10032

Other trials in United States

Poland2 sites

  • Szpital Specjalistyczny im. Sw. Rodziny SPZOZ

    Warsaw, 02-544

  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798

Other trials in Poland

About this study

Official title: 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

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
Being tested
PF-07225570, sasanlimab
Keywords
Recurrent Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial cancer, Toll-like receptor 7 (TLR7), Toll-like receptor 8 (TLR8)
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07225570Drug

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

  • sasanlimabDrug

    Also called anti-PD-1 (programmed cell death protein-1) antibody

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

Study groups in NCT05259397
Study groupRoleWhat they receive
Part 1A PF-07225570 monotherapyExperimentalIntravesical (IVe) Single Agent Dose Escalation
Receives: Drug: PF-07225570
Part 1B PF-07225570 and sasanlimabExperimentalPF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation
Receives: Drug: PF-07225570; Drug: sasanlimab
Part 2A PF-07225570 monotherapyExperimentalIVe Single Agent Dose Expansion
Receives: Drug: PF-07225570
Part 2B PF-07225570 and sasanlimabExperimentalPF-07225570 IVe and sasanlimab SQ Combination Dose Expansion
Receives: Drug: PF-07225570; Drug: sasanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Dose limiting toxicities

    Measured: Baseline up to 28 days

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

    Measured: Baseline up to approximately 24 months

  3. Number of Participants with AEs according to Seriousness

    Measured: Baseline up to approximately 24 months

  4. Number of Participants with AEs according to Relationship

    Measured: Baseline up to approximately 24 months

Secondary outcomes (17)

  1. Proportion of participants with carcinoma in situ (CIS) achieving complete response at any time after first dose of PF 07225570

    Measured: Baseline up to 24 months

  2. 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

    Measured: Baseline up to 24 months

  3. For participants with high-grade Ta/ T1 disease only, Proportion of participants without high-grade-recurrence at each assessment visit.

    Ta is defined as the stage of bladder cancer as a non-invasive papillary carcinoma. T1 is defined as the stage of cancer in which the cancer cells are only growing in the most superficial layer of tissues and have not grown into deeper tissues; in bladder cancer, T1 is defined as an invasion into the lamina propria without invasion into the muscularis propria

    Measured: Baseline up to 24 months

  4. Maximum Observed Plasma Concentration (Cmax) of PF-7225570 after a single dose

    Measured: 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

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07225570 after a single dose

    Measured: 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

  6. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07225570 after a single dose

    Measured: 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

  7. Concentration from maximum to steady state (Cmax,ss) of PF-07225570 after multiple doses

    Measured: Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation

  8. Time from maximum concentration to steady state (Tmax,ss) of PF-07225570 after multiple doses

    Measured: Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation

  9. Area under the curve from specified time to steady state (AUCτ,ss) of PF-07225570 after multiple doses

    Measured: Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation

  10. Urine PF-07225570 concentration after a single dose

    Measured: 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

  11. Urine PF-07225570 concentration after multiple doses

    Measured: Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours and 2 - 4 hours post-instillation.

  12. Progression-Free Survival

    Measured: Baseline up to 24 months

  13. Incidence of Radical Cystectomy

    Measured: Baseline up to 24 months

  14. Overall survival

    Measured: Baseline up to 3 years

  15. Serum sasanlimab concentrations

    Measured: Pre-dose (within 6 hours) before each administration

  16. Incidence and titers of neutralizing antibodies (NAb) against sasanlimab

    Measured: Pre-dose (within 6 hours) before each administration

  17. Incidence and titers of anti-drug antibodies (ADA) against sasanlimab

    Measured: Pre-dose (within 6 hours) before each administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start24 Mar 2022
  3. Primary completion19 Sep 2022
  4. Study completion19 Sep 2022

Why it stopped: Pfizer has decided to terminate Study C4661001 due to strategic considerations. This decision is not due to any specific safety reasons or requests from any regulatory authorities. No participants have been enrolled in this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259397
Sponsor's protocol ID
C4661001
Other IDs
2021-005858-28
Status last verified
Mar 2023
First submitted
15 Feb 2022
Last updated
8 Mar 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07225570 and sasanlimab in people with Bladder Cancer, run by Pfizer at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose limiting toxicities (time frame: Baseline up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.

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