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.
Checked against the public recordLast updated Apr 12, 2024 · Source: ClinicalTrials.gov
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
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
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.