Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 18, 2025
  • participants needed
    120
  • sponsor
    Pfizer
Updated on 4 October 2022
combination therapy
monoclonal antibodies
measurable disease
growth factor
programmed cell death 1 ligand 1

Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 [PD-1] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them.

The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.

Details
Condition Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer, Hepatocellular Cancer, Bladder Cancer, Sarcoma, Head and Neck Cancer, Colorectal Cancer, Ovarian Cancer, Squamous Cell Carcinoma
Treatment Sasanlimab, PF-07263689
Clinical Study IdentifierNCT05061537
SponsorPfizer
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents
Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 [PDL1] if applicable) or for whom no standard therapy is available for their tumor type
Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020)
Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only)
Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy
Eastern Cooperative Oncology Group (ECOG) PS 0-1
Adequate hematologic, renal, and liver functions
Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria
Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2)

Exclusion Criteria

Other active malignancy
Recent major surgery
Systemic anticancer therapy and chemotherapy within protocol-defined washout period
Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years
Current or history of myocarditis or congestive heart failure (New York Heart Association [NYHA] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction
Active or history of interstitial lung disease (ILD)/pneumonitis
Patients requiring chronic systemic immunosuppressants
History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy
Known symptomatic brain metastases requiring steroids
History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment
Any prior or planned organ transplant
Presence of any open, active wound requiring treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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