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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
Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor
Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor
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 belowSelect...
My cancer has worsened after treatment, including a checkpoint inhibitor.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through up to 2 years
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 moreSecondary 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 moreTrial 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
4,580 Previous Clinical Trials
14,634,182 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,811,057 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2A Dose Expansion Combination (NSCLC)
- Group 2: Part 2A Dose Expansion Combination (selected tumor types)
- Group 3: Part 1B Dose Escalation Combination
- Group 4: Part 2A Dose Expansion Combination (Gastric/GEJ)
- Group 5: Part 2A Dose Expansion Combination (SCCHN)
- Group 6: Part 2A Dose Expansion Combination (UC)
- Group 7: Part 2B Dose Expansion Monotherapy (selected tumor types)
- Group 8: Part 1A Dose Escalation Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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