Trials / Withdrawn
WithdrawnNCT05259397
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07225570 | PF-07225570 given IVe in a 28-day cycle (as induction and maintenance regimen). Multiple dose levels will be evaluated. |
| DRUG | sasanlimab | Sasanlimab will be administered SQ on day 1 of each 28 day cycle. |
Timeline
- Start date
- 2022-03-24
- Primary completion
- 2022-09-19
- Completion
- 2022-09-19
- First posted
- 2022-02-28
- Last updated
- 2023-03-08
Locations
4 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05259397. Inclusion in this directory is not an endorsement.