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PF-07265028 + Sasanlimab for Advanced Cancers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has spread to my brain.You have a tumor that can be measured using specific guidelines for evaluating tumor response.I need a recent tumor biopsy or have one from the last 3 months after my last cancer treatment.I have recovered from the side effects of my previous treatments.My cancer has worsened after treatment, including a checkpoint inhibitor.I haven't had major heart or lung issues in the last 6 months.My cancer has spread, doesn't respond to standard treatments, or I can't tolerate them.My advanced cancer has worsened after treatment, including an immunotherapy drug.I have a stomach or intestine problem that affects how my body absorbs medicine.I have not had any other cancer in the last 3 years.I have a history of lung conditions like interstitial lung disease or pneumonitis.I have had severe side effects from previous immune therapy.You have a current autoimmune condition or a history of autoimmune diseases that might come back.I am fully active or can carry out light work.I have never taken HPK1 inhibitor medication.My blood, kidney, and liver tests are within normal ranges.I do not have any ongoing serious infections.
- Group 1: Part 2B Dose Expansion Monotherapy (selected tumor types)
- Group 2: Part 2A Dose Expansion Combination (selected tumor types)
- Group 3: Part 2A Dose Expansion Combination (NSCLC)
- Group 4: Part 1A Dose Escalation Monotherapy
- Group 5: Part 1B Dose Escalation Combination
- Group 6: Part 2A Dose Expansion Combination (SCCHN)
- Group 7: Part 2A Dose Expansion Combination (UC)
- Group 8: Part 2A Dose Expansion Combination (Gastric/GEJ)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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