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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

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 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

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,757 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,366 Total Patients Enrolled
~3 spots leftby Jul 2025