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


About this study

The purpose of this FIH study is to assess the safety and tolerability, effectiveness, pharnacokinetcs (PK), and pharmacodynamics (PD) of increasing dose levels of PF-07257876; to identify the MTD and potential RP2D of PF-07257876; and to select the RP2D for further studies in development. This study will enroll patients with advanced cancers with no curative therapy (NSCLC, SCCHN, and OvCa) whose tumors have either failed prior PD-1 or PD-L1 therapies (NSCLC or SCCHN); or platinum-based chemotherapy (OvCa). In addition, patients’ tumors must have demonstrated PD-L1 expression > 1%.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- 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

Eligibility last updated  2/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Panayiotis Savvides, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


Jacksonville, Fla.

Mayo Clinic principal investigator

Yujie Zhao, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


Rochester, Minn.

Mayo Clinic principal investigator

Saravut Weroha, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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