A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Non-muscle Invasive Bladder Cancer
Спонсор: Pfizer
Налично на:
БГ
Обобщение
The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab.
This study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them.
The study has three parts:
* Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments.
* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments.
* Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and/or sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments.
All participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and/or sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.
For all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.
Кой може да участва
INCLUSION CRITERIA:
1. 18 years of age or older (or the minimum age of consent per local regulations)
2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1/Ta papillary disease. Note: High-grade T1/Ta papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3
3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.
4. Have refused or are ineligible or not appropriate for radical cystectomy
5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment
6. ECOG PS 0 or 1
EXCLUSION CRITERIA:
1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
3. Participants with active, uncontrolled infection as specified in the protocol
Интервенции
PF-08052667
DRUG
Sasanlimab
DRUG
BCG
DRUG
PF-02921367
DRUG
Места на провеждане
47
Франция (1)
Gustave Roussy
Villejuif , VAL DE Marne
NOT_YET_RECRUITING
Израел (3)
Hadassah Medical Center
Jerusalem , Jerusalem
Rabin Medical Center
Petah Tikva , Central District
Sheba Medical Center
Ramat Gan , Central District
Южна Корея (3)
Samsung Medical Center
Seoul , Seoul Teukbyeolsi [seoul]
NOT_YET_RECRUITING
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [seoul]
NOT_YET_RECRUITING
Severance Hospital, Yonsei University Health System
Seoul , Seoul-teukbyeolsi
NOT_YET_RECRUITING
Испания (1)
Hospital Universitario 12 de Octubre
Madrid
САЩ (39)
Emory University Hospital Midtown
Atlanta , Georgia
Emory University Hospital
Atlanta , Georgia
Emory University
Atlanta , Georgia
University of Alabama at Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
University of Alabama at Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
University of Alabama at Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
Northwestern Memorial Hospital
Chicago , Illinois
NOT_YET_RECRUITING
Northwestern University - Feinberg School of Medicine
Chicago , Illinois
NOT_YET_RECRUITING
UT Southwestern Medical Center
Dallas , Texas
NOT_YET_RECRUITING
Duke Cancer Institute
Durham , North Carolina
Substrate Services Core Research Support (SSCRS)
Durham , North Carolina
Biorepository and Precision Pathology Center (BRPC)
Durham , North Carolina
The University of Kansas - Clinical Research Center
Fairway , Kansas
University of Iowa Health Care
Iowa City , Iowa
NOT_YET_RECRUITING
The University of Kansas Hospital Cambridge North Tower A
Kansas City , Kansas
The University of Kansas Hospital
Kansas City , Kansas
The University of Kansas Medical Center Medical Office Building
Kansas City , Kansas
Grand Strand Medical Center
Myrtle Beach , South Carolina
AUC Urologists, LLC
Myrtle Beach , South Carolina
Carolina Urologic Research Center, LLC
Myrtle Beach , South Carolina
Parkway Surgery Center
Myrtle Beach , South Carolina
Coastal Eye Group
Myrtle Beach , South Carolina
Urology Associates, P.C.
Nashville , Tennessee
Icahn School of Medicine at Mount Sinai
New York , New York
NOT_YET_RECRUITING
AdventHealth Orlando
Orlando , Florida
NOT_YET_RECRUITING
The University of Kansas Hospital - Indian Creek Campus