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

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer, Hepatocellular Cancer, Bladder Cancer

Interventions: PF-07263689, Sasanlimab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Duarte, California, United States
New York, New York, United States
New York, New York, United States