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Virus Therapy

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

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
No Placebo-Only Group

Summary

This trial is testing a new drug called PF-07263689, both by itself and with another experimental drug, sasanlimab. It targets patients with advanced or spreading tumors who have no other treatment options left. The goal is to see if PF-07263689 can shrink or slow down tumors, and if combining it with sasanlimab can help the immune system fight cancer better.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Part 1: Duration of Response
Part 1: Objective Response Rate
Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4,669 Previous Clinical Trials
17,861,911 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,913 Total Patients Enrolled
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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