Ovarian Cancer Clinical Trial

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.

Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histological/cytological diagnosis of selected advanced or metastatic tumor
Prior treatment with PD-1 (Programmed cell death 1) or PD-L1 (programmed death-ligand 1) in NSCLC and SCCHN or platinum-based therapy in Ovarian cancer
Confirmed radiographic progression of disease
PD-L1 IHC positivity ≥1%
Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
Eastern Cooperative Oncology Group performance status 0-1
Adequate hematologic, renal and liver functions
Resolved acute effects of any prior therapy
Participants in Part 1 must be able to provide archival tumor tissue collected within the prior 6 months or consent to undergo a fresh biopsy during screening. Participants enrolled to the MTD (Maximum Tolerated Dose) cohort in Part 1 must consent to mandatory paired pre-treatment and on-treatment biopsies. Participants in Part 2 must consent to a pre-treatment biopsy and a subset of patients must consent to a paired on-study biopsy as well until the Sponsor deems an adequate number have been received.

Exclusion Criteria:

Participants with known brain metastasis larger than 4 cm or that is symptomatic. New brain metastases detected at screening. Participants with previously diagnosed brain metastases are eligible if they have completed treatment and recovered from acute effects prior to study entry.
Abnormal neurological assessment by investigator
Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Major surgery or radiation therapy within 4 weeks prior to planned first dose
Last systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas)
Active bleeding disorder in the past 6 months prior to first dose
History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia), evidence of active pneumonitis on screening chest CT(computer tomography) scan
Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed
Treatment with chronic systemic corticosteroids or other immunosuppressive medications
Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
Active, uncontrolled bacterial, fungal, or viral infection, Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) infection
Active COVID-19/SARS-CoV2
Pregnant or breastfeeding female participant
Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
Significant cardiac or pulmonary conditions or events within previous 6 months

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04881045

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 32 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
Mayo Clinic
Scottsdale Arizona, 85259, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Hoag Hospital Irvine
Irvine California, 92618, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles California, 90025, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
Keck School of Medicine of USC
Los Angeles California, 90033, United States
LAC+USC Medical Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
Keck Hospital of USC Pasadena
Pasadena California, 91105, United States
Keck Medical Center of USC Pasadena
Pasadena California, 91105, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
Santa Monica California, 90404, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Siteman Cancer Center-North County
Florissant Missouri, 63031, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - St Peters
Saint Peters Missouri, 63376, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Duke Cancer Institute
Durham North Carolina, 27710, United States
UPMC Hillman Cancer Center - Camp Hill
Camp Hill Pennsylvania, 17011, United States
UPMC Hillman Cancer Center - Carlisle
Carlisle Pennsylvania, 17015, United States
UPMC Hillman Cancer Center Erie
Erie Pennsylvania, 16505, United States
UPMC Pinnacle - Community Osteopathic / Medical Sciences Pavilion (MSP)
Harrisburg Pennsylvania, 17109, United States
UPMC Pinnacle - Ortenzio Cancer Center (OCC)
Mechanicsburg Pennsylvania, 17050, United States
Magee-Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
UPMC Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States
UPMC Memorial
York Pennsylvania, 17408, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
The Miriam Hospital
Providence Rhode Island, 02906, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04881045

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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