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Monoclonal Antibodies
PF-07820435 + Sasanlimab for 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 baseline through up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of PF-07820435 alone or in combination with sasanlimab in patients with advanced or metastatic solid tumors. The first part of the study
Who is the study for?
This trial is for adults with certain advanced cancers (like lung, kidney, colorectal) who've tried standard treatments without success or can't tolerate them. They need at least one measurable tumor and must provide tissue samples. It's not open to those who haven't had specific prior therapies if available and tolerable.
What is being tested?
The study tests PF-07820435 alone and with Sasanlimab in patients with advanced solid tumors. Part 1 finds the best dose; Part 2 uses this dose to see how well it works in different cancer types.
What are the potential side effects?
While the side effects aren't listed here, similar cancer drugs often cause fatigue, nausea, skin reactions, immune-related issues like inflammation of organs, and increased infection risk.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with adverse events (AEs)
Number of patients with clinically significant lab abnormalities
Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B)
+1 moreSecondary study objectives
AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite
Change from baseline of immune markers within biopsied tumor tissue
+10 moreAwards & 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-07820435 orally at the prescribed dose and frequency in 28-day cycles
Group II: Expansion (Part 2) - Tumor specific Arm BExperimental Treatment2 Interventions
Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles
Group III: Expansion (Part 2) - Tumor specific Arm AExperimental Treatment2 Interventions
Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles
Group IV: Expansion (Part 2) - Arm CExperimental Treatment1 Intervention
Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles
Group V: Combination dose escalation (Part 1B)Experimental Treatment2 Interventions
Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,176 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,032 Total Patients Enrolled