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PF-07826390 for Cancer

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
Able to provide pre-treatment (and optional on-treatment) tumor tissue
Must not have
Prior treatment with another LILRB1 (ILT2), LILRB2 (ILT4), and/or LILRB1/2 (B1 and B2) antagonist antibodies or pathway targeting agents, including HLA conformers and HLA-G antibodies
Lack of adequate organ (bone marrow, renal, liver) function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at how safe and effective a new medication is for treating solid tumors such as Non-Small Cell Lung Cancer, Colorectal Cancer, and Renal Cell Carcinoma. Participants

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including specific types of lung, colorectal, and kidney cancers. Participants must have tried certain standard treatments without success or be unable to tolerate them. They should have at least one measurable tumor lesion and be able to provide tissue samples.
What is being tested?
The study tests PF-07826390 alone or combined with sasanlimab (an anti-cancer medication) in people with cancer. It aims to determine the safest and most effective dosage. Patients will receive these medications through IV infusion or shots under the skin every four weeks.
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as fatigue, nausea, inflammation in organs, allergic reactions from infusions, and possibly an increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.
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I can provide samples of my tumor before (and possibly during) treatment.
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I have colorectal cancer and have received specific treatments, or I have kidney cancer and have tried or cannot tolerate certain therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been treated with specific immune-targeting drugs for my condition.
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My kidney, liver, and bone marrow are not working well.
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I had a severe reaction to previous immune therapy that needed treatment.
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I haven't had cancer treatment in the last 4 weeks or 5 half-lives, whichever is shorter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 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 & 2: Incidence of Adverse Events (AE)s
PART 1 & 2: Number of participants with laboratory abnormalities
PART 1: Number of participants with Dose-limiting toxicities (DLT)
+1 more
Secondary study objectives
Objective Response - Number of Participants with Objective Response
Part 1 and Part 2: Incidence and titers of antidrug antibodies (ADA) against PF-07826390
Part 1 and Part 2: Paried Tumor Biopsies
+17 more

Awards & Highlights

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

Trial Design

7Treatment groups
Experimental Treatment
Group I: Part 2C: PF-07826390 + SOCExperimental Treatment2 Interventions
PF-07826390 + SOC (anti-PD-1 + platinum -based chemo) dose expansion for a PDx-naive NSCLC 1L at prescribed dose and frequency in 28-day cycles
Group II: Part 2B: PF-07826390Experimental Treatment1 Intervention
PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
Group III: Part 2A (Arm 3): PF-07826390 + sasanlimabExperimental Treatment2 Interventions
PF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles
Group IV: Part 2A (Arm 2): PF-07826390 + sasanlimabExperimental Treatment2 Interventions
PF-07826390 + sasanlimab dose expansion in MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles
Group V: Part 2A (Arm 1): PF-07826390 + sasanlimabExperimental Treatment2 Interventions
PF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
Group VI: Part 1B: PF-07826390 + sasanlimabExperimental Treatment2 Interventions
PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles
Group VII: Part 1A: PF-07826390 MonotherapyExperimental Treatment1 Intervention
PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,646 Previous Clinical Trials
17,743,321 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,534 Previous Clinical Trials
14,914,688 Total Patients Enrolled
~127 spots leftby Feb 2029
Unbiased ResultsWe believe in providing patients with all the options.
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