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Monoclonal Antibodies

PF-07934040 + Other Anti-Cancer Therapies for Non-Small Cell Lung 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
ECOG PS 0 or 1
Must not have
Diagnosis of immunodeficiency or an active autoimmune disease that require systemic treatment with chronic systemic steroid therapy
Renal impairment
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 aims to test the safety and effectiveness of a new medication, PF-07934040, either alone or in combination with other anti-cancer treatments. They are looking for participants with advanced solid

Who is the study for?
This trial is for adults with advanced solid tumors that have a KRAS gene mutation and have progressed after standard treatments. It includes specific cancers like NSCLC, CRC, and PDAC. Participants must have tried previous therapies without success and should be in good physical condition (ECOG PS 0 or 1).
What is being tested?
The study tests PF-07934040 alone or combined with other anti-cancer drugs (like Paclitaxel, Carboplatin) given orally or intravenously over cycles of 21 to 28 days. The goal is to determine the safety, effective dose, and effects on various advanced cancers.
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, hair loss; immune-related issues due to Pembrolizumab; bleeding risks from Bevacizumab; skin reactions from Cetuximab; and any new side effects related to PF-07934040.

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 am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one tumor that can be measured and hasn't been treated with radiation.
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My cancer has a KRAS gene mutation.
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My condition worsened despite treatment and no other effective options are available.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder that needs long-term steroids.
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I have kidney problems.
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I have or had lung inflammation or scarring treated with steroids.
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I have liver problems.
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I have moderate to severe numbness or pain in my hands or feet.
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I have or had a serious stomach or intestine disease.
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I have a condition that causes me to bleed easily.
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I haven't had major surgery or finished radiation therapy within the last 4 weeks.

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: Number of participants with laboratory abnormalities
Part 1 & 2: Incidence of Adverse Events (AEs)
Part 1: Number of participants with Dose-limiting toxicities (DLT)
+1 more
Secondary study objectives
Part 1 & 2: Changes in pERK levels
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Part 1 & 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
+5 more

Awards & Highlights

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

Trial Design

9Treatment groups
Experimental Treatment
Group I: Part 2b Cohort C3Experimental Treatment6 Interventions
Combination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
Group II: Part 2b Cohort C2Experimental Treatment2 Interventions
Combination (PF-07934040 + Pembro) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day cycles
Group III: Part 2b Cohort B3Experimental Treatment5 Interventions
Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Group IV: Part 2b Cohort B2Experimental Treatment2 Interventions
Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
Group V: Part 2b Cohort A2Experimental Treatment3 Interventions
Combination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
Group VI: Part 2a Cohort C1Experimental Treatment1 Intervention
Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Group VII: Part 2a Cohort B1Experimental Treatment1 Intervention
Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Group VIII: Part 2a Cohort A1Experimental Treatment1 Intervention
Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Group IX: Part 1Experimental Treatment1 Intervention
PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pemetrexed
2005
Completed Phase 3
~5000
Cisplatin
2013
Completed Phase 3
~3120
Oxaliplatin
2011
Completed Phase 4
~2890
Bevacizumab
2013
Completed Phase 4
~5540
Pembrolizumab
2017
Completed Phase 3
~3150
Nab-paclitaxel
2014
Completed Phase 3
~1950
Leucovorin
2005
Completed Phase 4
~6010
Paclitaxel
2011
Completed Phase 4
~5450
Carboplatin
2014
Completed Phase 3
~6120
Gemcitabine
2017
Completed Phase 3
~1920
Cetuximab
2011
Completed Phase 3
~2480
Fluorouracil
2014
Completed Phase 3
~11700

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,595 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,885,751 Total Patients Enrolled
~220 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
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