Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.
Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring PD-L1 (Programmed death-ligand 1), CD47 (cluster of differentiation 47), immunotherapy, macrophage checkpoint inhibitor, advanced solid tumor, metastatic solid tumor, Ovarian Cancer, Lung Cancer, Non-small cell lung cancer, Head and Neck cancer, SCCHN, NSCLC, solid tumor, advanced cancer, metastatic cancer, Squamous cell carcinoma of the head and neck, Squamous cell head and neck cancer
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
Sites / Locations
- Mayo Clinic Hospital
- Mayo Clinic
- Highlands Oncology Group
- Highlands Oncology Group
- Highlands Oncology Group
- Hoag Hospital Irvine
- The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
- Keck Hospital of USC
- Keck School of Medicine of USC
- LAC+USC Medical Center
- USC/Norris Comprehensive Cancer Center
- Hoag Memorial Hospital Presbyterian
- Keck Hospital of USC Pasadena
- The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
- Mayo Clinic Jacksonville
- Mayo Clinic Rochester
- Siteman Cancer Center - West County
- Siteman Cancer Center-North County
- Barnes-Jewish Hospital
- Washington University School of Medicine
- Washington University
- Siteman Cancer Center - South County
- Siteman Cancer Center - St Peters
- Hackensack University Medical Center
- John Theurer Cancer Center at Hackensack University Medical Center
- Duke Cancer Institute
- UPMC Hillman Cancer Center - Camp Hill
- UPMC Hillman Cancer Center - Carlisle
- UPMC Hillman Cancer Center Erie
- UPMC Pinnacle - Community Osteopathic / Medical Sciences Pavilion (MSP)
- UPMC Pinnacle - Ortenzio Cancer Center (OCC)
- Magee-Womens Hospital of UPMC
- UPMC Hillman Cancer Center
- UPMC Shadyside Hospital
- UPMC Memorial
- Rhode Island Hospital
- The Miriam Hospital
- Virginia Cancer Specialists
- Seattle Cancer Care Alliance
- Hospital Universitari Vall d'Hebron
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario 12 de Octubre
- Hospital Clinico de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Dose Escalation (Part 1)
Dose Expansion (Part 2) - Cohort 1 (NSCLC)
Dose Expansion (Part 2) - Cohort 2 (SCCHN)
Participants will receive PF-07257876 at escalating dose levels.
Participants with non-small cell lung cancer (NSCLC) will receive PF-07257876 at the recommended dose from Part 1.
Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07257876 at the recommended dose from Part 1.