Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 12, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Biological: PF-07263689; Biological: Sasanlimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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)
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- Columbia University Medical CenterNew York, New York
- CUMC Research PharmacyNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 12, 2024. Always confirm current availability with the study team.