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Virus Therapy

PF-07263689 for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of study treatment until cr, pr or sd (up to 2 years)

Awards & highlights

Study Summary

This trial is testing a new drug (PF-07263689) to see if it is safe and effective at treating certain solid tumors. The trial is divided into two parts: Part 1 is testing different doses of the drug to see what is safe and effective, while Part 2 is expanding the testing to include a combination of the new drug with another drug (sasanlimab).

Eligible Conditions

Non-Small Cell Lung Cancer
Colorectal Cancer
Squamous Cell Carcinoma
Ovarian Cancer
Kidney Cancer
Melanoma
Liver Cancer
Bladder Cancer
Sarcoma
Head and Neck Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of study treatment until cr, pr or sd (up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of study treatment until cr, pr or sd (up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment until cr, pr or sd (up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade

+6 more

Secondary outcome measures

Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood

Part 1: Duration of Response

Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood

+22 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalation (Part 1A)Experimental Treatment1 Intervention

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

Group II: Dose expansion (Part 2) - Tumor specific Arm CExperimental Treatment2 Interventions

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

Group III: Dose expansion (Part 2) - Tumor specific Arm BExperimental Treatment2 Interventions

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

Group IV: Dose expansion (Part 2) - Tumor specific Arm AExperimental Treatment2 Interventions

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

Group V: Combination dose escalation (Part 1B)Experimental Treatment2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,568 Previous Clinical Trials

10,911,873 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,093,041 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has PF-07263689 been officially sanctioned by the Food and Drug Administration?

"The safety of PF-07263689 has been preliminarily assessed as a 1 on the scale due to its Phase 1 status, which implies limited data exists that supports both efficacy and security."

Answered by AI

Are there any vacancies available for potential participants in this clinical trial?

"As per the information published on clinicaltrials.gov, this project is not actively seeking enrollees at present. The research was first made available on October 20th 2021 and last modified November 8th 2022; however, there are 3,970 other trials that have open recruitment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of PF-07263689 in Participants With Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061537.