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PF-07265807 + Sasanlimab + Axitinib for Advanced Cancer

Q: How many sites have been selected for this experiment's implementation?

<p>Highlands <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group in Rogers, <a href="https://www.withpower.com/clinical-trials/arkansas">Arkansas</a>, Community Health Network <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center North in Fayetteville, <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> and Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus in Indianapolis are just some of the places conducting this trial. An additional 27 medical centres also participate.</p>

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

Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy

Adequate Bone Marrow Function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through approximately 2 years

Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it works in people with advanced cancer.

Who is the study for?

This trial is for adults with certain advanced cancers who've tried other treatments without success. They should be relatively active (ECOG 0 or 1, sometimes 2), have a life expectancy over 3 months, and their cancer must meet specific criteria based on type and previous treatments. Major organ functions need to be adequate, and they can't have uncontrolled high blood pressure or serious health issues that could interfere with the study.Check my eligibility

What is being tested?

The study tests PF-07265807 alone and combined with Sasanlimab or Axitinib in patients with metastatic solid tumors. It aims to understand how these drugs are processed by the body, their safety levels, and how well they're tolerated when given individually or together.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation of organs like lungs (pneumonitis), fatigue, digestive disturbances, skin issues, potential bleeding disorders due to drug interactions or pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My NSCLC has a METex14 mutation and has worsened after treatment.

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My bone marrow is working well.

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I can provide samples of my tumor for testing.

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I cannot tolerate or my cancer does not respond to standard treatments.

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My stomach cancer is PD-L1 positive and has worsened after 2-3 chemotherapy treatments but I haven't had anti-PD-(L)1 therapy.

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I have metastatic RCC with clear cell component and haven't had systemic therapy for it.

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My kidney cancer has spread, and there's no standard treatment left for me.

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I have at least one cancer lesion that hasn't been treated with radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 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

Part 4, Cohort 4: Complete Response (CR)

Part 4: Overall Response Rate (ORR)

Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)

+2 more

Secondary outcome measures

Disease Control Rate

Duration of Response

Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib

+26 more

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02129647

30%

Mucositis

10%

Fatigue

10%

Rash

10%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Axitinib

Trial Design

7Treatment groups

Experimental Treatment

Group I: Triplet Dose Escalation: Part 3Experimental Treatment3 Interventions

Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.

Group II: Monotherapy Dose Escalation: Part 1Experimental Treatment1 Intervention

Monotherapy dose escalation of PF-07265807 in participants with select tumor types.

Group III: Expansion Phase: Part 4, Cohort 4Experimental Treatment3 Interventions

PF-07265807 with sasanlimab plus axitinib in participants with RCC

Group IV: Expansion Phase: Part 4, Cohort 3Experimental Treatment2 Interventions

PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ

Group V: Expansion Phase: Part 4, Cohort 2Experimental Treatment2 Interventions

PF-07265807 with sasanlimab in participants with MSS CRC

Group VI: Expansion Phase: Part 4, Cohort 1Experimental Treatment1 Intervention

PF-07265807 monotherapy in participants with METex14 mutant NSCLC.

Group VII: Doublet Dose Escalation: Part 2Experimental Treatment2 Interventions

Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,568 Previous Clinical Trials

10,911,819 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,092,987 Total Patients Enrolled

Media Library

PF-07265807 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04458259 — Phase 1

Cancer Research Study Groups: Triplet Dose Escalation: Part 3, Monotherapy Dose Escalation: Part 1, Doublet Dose Escalation: Part 2, Expansion Phase: Part 4, Cohort 1, Expansion Phase: Part 4, Cohort 2, Expansion Phase: Part 4, Cohort 3, Expansion Phase: Part 4, Cohort 4

Cancer Clinical Trial 2023: PF-07265807 Highlights & Side Effects. Trial Name: NCT04458259 — Phase 1

PF-07265807 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458259 — Phase 1

Frequently Asked Questions

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

Does this experimental trial break new ground?

"Since 2011, scientific research has been conducted on PF-07265807. Initially backed by Pfizer in 2011, the drug was granted Phase 2 approval after a study of 39 participants. Currently there are 48 active studies for this medication reaching 30 countries and over 386 cities worldwide."

Answered by AI

Have any other trials utilized PF-07265807 as a therapeutic measure?

"Currently, 48 studies are being conducted on the medication PF-07265807. Of these experiments, 4 of them have achieved Phase 3 status. Although the majority of trials for this drug take place in Houston, Texas there exist 1038 locations conducting research worldwide."

Answered by AI

Does PF-07265807 pose any potential dangers to individuals?

"Our assessment of PF-07265807's safety is 1, as this initial trial has only a minimal amount of data to support its effectiveness and overall security."

Answered by AI

How many sites have been selected for this experiment's implementation?

"Highlands Oncology Group in Rogers, Arkansas, Community Health Network Cancer Center North in Fayetteville, Indiana and Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus in Indianapolis are just some of the places conducting this trial. An additional 27 medical centres also participate."

Answered by AI

What is the main purpose of this clinical trial?

"The overall aim of this research project, which will be monitored over a two-year Baseline period, is to discover the dose limiting toxicities associated with PF-07265807. Additionally, we also hope to uncover Single and multiple plasma concentration (Cmin), maximum plasma concentrations (Cmax) and its related normalized values (Cmax(dn)), as well as area under the curve from time of initial dosing till last measurable concentrations (AUClast/ AUClast(dn))."

Answered by AI

How many people have signed up for participation in this clinical trial?

"Confirmed, the clinical trial's information hosted on clinicaltrials.gov states that enrollment is currently open. Originally posted on September 24th 2020, it was most recently updated on November 8th 2022 and seeks to recruit 161 individuals from 27 medical centres."

Answered by AI

Is this research project currently accepting participants?

"That is correct. The information posted on clinicaltrials.gov demonstrates that this medical trial, first announced on September 24th 2020, is currently recruiting patients. 161 participants are needed from 27 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

2020. "Study of PF-07265807 in Participants With Metastatic Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04458259.

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