What side effects are associated with this type of intervention?

Common cancer treatments, particularly chemotherapy, are associated with a range of side effects. Neuropathy, characterized by numbness and tingling, is prevalent, especially with agents like oxaliplatin and paclitaxel. Gastrointestinal issues such as diarrhea, nausea, vomiting, and stomatitis are also frequent, as seen with fluorouracil and capecitabine. Hematologic toxicities, including neutropenia and anemia, are common, particularly with drugs like gemcitabine and pemetrexed. Additionally, alopecia (hair loss) is a notable side effect, often observed with taxane-based therapies. These side effects can significantly impact the quality of life and may require supportive care measures.

What prior FDA approvals exist?

The FDA has approved several innovative treatments for advanced or metastatic cancers, including pembrolizumab and nivolumab, which are immune checkpoint inhibitors used for various malignancies. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for prostate cancer. These therapies, which involve novel mechanisms of action, reflect the ongoing advancements in cancer treatment, similar to the investigational drug PF-07265807 being studied for metastatic solid tumors.

What other types of research exist?

Promising novel alternatives for cancer treatment in 2024 include: 1) Regorafenib, a multitargeted kinase inhibitor showing activity in osteosarcoma; 2) Temsirolimus, an mTOR inhibitor with some efficacy in endometrial cancer; 3) Everolimus combined with letrozole, showing clinical benefit in endometrial cancer; 4) Futibatinib, an FGFR2 inhibitor for cholangiocarcinoma; 5) Nivolumab, a PD-1 inhibitor showing activity in meningioma. These agents target various pathways and have shown potential in clinical trials.

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Other

PF-07265807 + Sasanlimab + Axitinib for Advanced 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

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

Adequate Bone Marrow Function

Must not have

Known active uncontrolled or symptomatic CNS metastases

Clinically significant cardiac disease as defined in protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through approximately 2 years

Awards & highlights

Summary

This trial is testing a new drug called PF-07265807 in people with advanced or spreading solid tumors. The goal is to understand how the drug moves through the body, its safety, and how well patients can handle it.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain metastases that are not under control.

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I do not have any major heart conditions.

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I have not had any other cancer in the last 2 years.

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I haven't had major surgery, radiation, or cancer drugs within the specified times before joining the study.

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I take more than 10mg/day of prednisone or other immunosuppressants for an autoimmune disease.

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I do not have an ongoing, untreated infection.

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I do not have serious eye problems.

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I have a chronic stomach or bowel condition that affects food absorption.

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I have a condition that causes me to bleed easily.

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My high blood pressure is not controlled by medication.

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I have not been treated with AXL/MERTK inhibitors before.

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I had a severe side effect from previous immunotherapy.

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I have had lung inflammation treated with steroids or have it now.

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I stopped my previous cancer immunotherapy due to side effects.

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I cannot take or absorb the medication needed for the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic agents to kill rapidly dividing cells, while targeted therapies, such as farnesyltransferase inhibitors, block specific molecular pathways essential for cancer cell survival and proliferation. Immunotherapies, like pembrolizumab, enhance the body's immune response against cancer cells. Investigational treatments, such as the ones being studied in the trial PF-07265807, often explore novel mechanisms, including disrupting cancer cell metabolism or signaling pathways. Understanding these mechanisms helps patients and doctors choose the most effective treatment, manage side effects, and improve overall outcomes.

Current trends and future directions in the genetic therapy of human neoplastic disease.Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.