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PF-07265028 + Sasanlimab for Advanced Cancers

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
Fresh tumor biopsy during screening is required unless there is archival tissues less than 3 months old and subsequent to the last systemic anti-cancer therapy
Resolved acute effects of any prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it works in people with cancer who have no other treatment options.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including specific cancers like lung and stomach cancer, who've tried other treatments without success. They must have measurable disease, provide tumor tissue samples, be in good physical condition (ECOG ≤1), and have proper organ function.Check my eligibility
What is being tested?
The study tests PF-07265028 alone and combined with Sasanlimab to find the highest dose patients can tolerate without severe side effects. It will also assess how well these treatments work against various solid tumors at this optimal dose over a period of up to one year.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to cancer therapies such as immune-related issues due to Sasanlimab (an immunotherapy drug) and any adverse effects related to PF-07265028's action on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a recent tumor biopsy or have one from the last 3 months after my last cancer treatment.
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I have recovered from the side effects of my previous treatments.
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My cancer has worsened after treatment, including a checkpoint inhibitor.
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My cancer has spread, doesn't respond to standard treatments, or I can't tolerate them.
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My advanced cancer has worsened after treatment, including an immunotherapy drug.
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I am fully active or can carry out light work.
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My blood, kidney, and liver tests are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 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
Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)
Number of participants with adverse events (AEs)
Number of participants with clinically significant laboratory abnormalities
+1 more
Secondary outcome measures
ORR in Dose Escalation (Part 1)
The effect of PF-07265028 alone and in combination with sasanlimab on tumor immune biomarkers modulation
The effect of food on the pharmacokinetic profile of PF-07265028 through AUC
+10 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Part 2B Dose Expansion Monotherapy (selected tumor types)Experimental Treatment1 Intervention
Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A.
Group II: Part 2A Dose Expansion Combination (selected tumor types)Experimental Treatment2 Interventions
Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Group III: Part 2A Dose Expansion Combination (UC)Experimental Treatment2 Interventions
Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Group IV: Part 2A Dose Expansion Combination (SCCHN)Experimental Treatment2 Interventions
Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Group V: Part 2A Dose Expansion Combination (NSCLC)Experimental Treatment2 Interventions
Participants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Group VI: Part 2A Dose Expansion Combination (Gastric/GEJ)Experimental Treatment2 Interventions
Participants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Group VII: Part 1B Dose Escalation CombinationExperimental Treatment2 Interventions
Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose
Group VIII: Part 1A Dose Escalation MonotherapyExperimental Treatment1 Intervention
Participants will receive PF-07265028 at escalating dose levels.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,665 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,102 Total Patients Enrolled

Media Library

PF-07265028 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05233436 — Phase 1
Stomach Cancer Research Study Groups: Part 2B Dose Expansion Monotherapy (selected tumor types), Part 2A Dose Expansion Combination (selected tumor types), Part 2A Dose Expansion Combination (NSCLC), Part 1A Dose Escalation Monotherapy, Part 1B Dose Escalation Combination, Part 2A Dose Expansion Combination (SCCHN), Part 2A Dose Expansion Combination (UC), Part 2A Dose Expansion Combination (Gastric/GEJ)
Stomach Cancer Clinical Trial 2023: PF-07265028 Highlights & Side Effects. Trial Name: NCT05233436 — Phase 1
PF-07265028 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233436 — Phase 1

Frequently Asked Questions

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

Has the Food and Drug Administration accepted PF-07265028 for therapeutic utilization?

"Due to the limited data available, PF-07265028 has been given a score of 1 on our safety scale. This is because this trial is only in its first phase and there are no clinical results demonstrating efficacy or safety yet."

Answered by AI

How many healthcare centers have enrolled in this trial?

"The experiment is currently running at 6 different sites, including some in San Antonio, Scottsdale and Grand Rapids. To reduce the burden of travel should you decide to participate, it's recommended that you select a clinic near your location."

Answered by AI

Are there still opportunities to enroll in this experiment?

"According to the clinicaltrials.gov database, this medical trial is actively sourcing participants who meet their criteria. This research project was originally publicized on February 24th 2022 and its most recent status update came through October 17th of that year."

Answered by AI

Is the age criteria for this medical research including octogenarians?

"The eligibility criteria for this clinical trial states that applicants must be aged 18 to 99. In comparison, 90 research trials exist for subjects below the age of majority and 3688 studies are available for patients over the retirement age."

Answered by AI

What is the ceiling for enrollment in this investigation?

"In order to adequately assess the efficacy of this trial, 240 eligible participants are needed in total. Those interested can enroll at various sites such as START San Antonio, Arizona and HonorHealth Scottsdale Shea Medical Center in Michigan."

Answered by AI

What are the projected outcomes of this experiment?

"The primary objective of this 28-day clinical trial is to assess the number of adverse events caused by PF-07265028. Additionally, secondary goals include measuring changes in intratumoral T cells and PD-L1 expression before and after treatment, determining how food can affect drug concentration peaks (Tmax), as well as evaluating duration of response (DOR) using RECIST 1.1 criteria during dose expansion phase 2."

Answered by AI

Can I join this experiment as a participant?

"To partake in this trial, candidates must possess a diagnosis of lung cancer and be between the ages of 18 to 99. The total amount of participants needed for completion is 240 individuals."

Answered by AI
~9 spots leftby Jul 2026