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Study of PF-07263689 in Participants With Selected Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY AND PHARMACODYNAMICS OF PF-07263689, EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PREVIOUSLY TREATED PARTICIPANTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

NCT05061537•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (3)

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

Key Dates

Start Date

October 20, 2021

Primary Completion Date

October 14, 2022

Completion Date

October 14, 2022

Last Updated

April 12, 2024

Enrollment

ACTUAL participants

Conditions

Renal Cell CancerMelanomaNon-Small-Cell Lung CancerHepatocellular CancerBladder CancerSarcomaHead and Neck CancerColorectal CancerOvarian CancerSquamous Cell Carcinoma

Interventions

PF-07263689

BIOLOGICAL

Sasanlimab

BIOLOGICAL

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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