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

NCT ID: NCT05061537

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-10-14

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monotherapy dose escalation (Part 1A)

Participants will receive PF-07263689 once a week for 4 doses

Group Type: EXPERIMENTAL

PF-07263689

Intervention Type: BIOLOGICAL

Genetically engineered oncolytic vaccinia virus

Combination dose escalation (Part 1B)

Participants will receive PF-07263689 intravenous (IV) once week for 4 doses in combination with sasanlimab subcutaneous (SC) once every 4 weeks

Group Type: EXPERIMENTAL

PF-07263689

Intervention Type: BIOLOGICAL

Genetically engineered oncolytic vaccinia virus

Sasanlimab

Intervention Type: BIOLOGICAL

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Dose expansion (Part 2) - Tumor specific Arm A

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Group Type: EXPERIMENTAL

PF-07263689

Intervention Type: BIOLOGICAL

Genetically engineered oncolytic vaccinia virus

Sasanlimab

Intervention Type: BIOLOGICAL

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Dose expansion (Part 2) - Tumor specific Arm B

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Group Type: EXPERIMENTAL

PF-07263689

Intervention Type: BIOLOGICAL

Genetically engineered oncolytic vaccinia virus

Sasanlimab

Intervention Type: BIOLOGICAL

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Dose expansion (Part 2) - Tumor specific Arm C

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Group Type: EXPERIMENTAL

PF-07263689

Intervention Type: BIOLOGICAL

Genetically engineered oncolytic vaccinia virus

Sasanlimab

Intervention Type: BIOLOGICAL

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Interventions

PF-07263689

Genetically engineered oncolytic vaccinia virus

Intervention Type: BIOLOGICAL

Sasanlimab

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

City of Hope

Duarte, California, United States

Columbia University Medical Center

New York, New York, United States

CUMC Research Pharmacy

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4651001

To obtain contact information for a study center near you, click here.

Other Identifiers

OBIR-2

Identifier Type: OTHER

Identifier Source: secondary_id

C4651001

Identifier Type: -

Identifier Source: org_study_id