Status:
COMPLETED
Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.
Lead Sponsor:
Pfizer
Conditions:
Non-Small Cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04881045
Start Date
August 18 2021
End Date
October 24 2023
Last Update
April 3 2024
Active Locations (43)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
4
Highlands Oncology Group
Rogers, Arkansas, United States, 72758