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Monoclonal Antibodies

Osimertinib + Carotuximab for Lung Cancer

Los Angeles, CA
Phase 1
Recruiting
Research Sponsored by Karen Reckamp, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
If the subject's most recent line of therapy is treatment with osimertinib, then all adverse events must be resolved to Grade 2 or better
Must not have
Acute cardiovascular event within the past 6 months.
Prior exposure to carotuximab or any CD105 targeted antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from baseline until eot, up to 2 years.
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, osimertinib and carotuximab, to treat advanced EGFR-mutated non-small cell lung cancer. The goal is to find the maximum tolerated dose of the combination by measuring the number of dose-limiting toxicities. Secondary objectives include evaluating the rate of objective response, duration of response, progression-free survival, and disease control rate.

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Who is the study for?
This trial is for adults with advanced non-squamous NSCLC that has specific EGFR mutations. Participants must have measurable disease, may have brain metastases if stable and asymptomatic, and should not have had recent major surgery or other cancer treatments. They need to agree to use contraception and be able to follow study requirements.Check my eligibility
What is being tested?
The study tests the combination of osimertinib with carotuximab in patients with EGFR-mutated NSCLC. It aims to determine the safest dose by monitoring adverse reactions, while also looking at how well tumors respond, how long they stop growing, survival without disease progression, and overall disease control.See study design
What are the potential side effects?
Potential side effects include those related to organ inflammation such as lung issues (but not pre-existing interstitial lung diseases), bleeding risks like ulcers or recent thrombolytics use, uncontrolled hypertension within a month before joining the trial, known allergies to certain antibodies or products from Chinese hamster ovary cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My side effects from osimertinib are mild or gone.
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My advanced lung cancer has a specific EGFR mutation.
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My cancer has worsened despite treatment with an EGFR inhibitor.
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I am 18 years old or older.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack or other major heart problem in the last 6 months.
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I have never been treated with carotuximab or any CD105 targeted antibody.
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I have fluid buildup needing drainage.
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I have a condition that causes heavy bleeding or I am currently experiencing heavy bleeding.
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I have a history of lung conditions needing steroid treatment.
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I have been diagnosed with Osler-Weber-Rendu syndrome.
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My lung cancer is of the small cell type.
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I have not had major surgery in the last 2 weeks.
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My cancer has spread to the lining of my brain and spinal cord.
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My blood pressure has been under control, with SBP ≤ 150 mmHg and DBP ≤ 90 mmHg in the last 28 days.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from baseline until eot, up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from baseline until eot, up to 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
The number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D) of combination of osimertinib with carotuximab in treatment of advanced, EGFR-mutated non-small cell lung cancer.
Secondary study objectives
Biomarkers of response to the combination using tumor tissue and serial ctDNA.
Biomarkers using tumor tissue and serial ctDNA for mutations.
Disease control rate
+3 more

Side effects data

From 2024 Phase 2 trial • 155 Patients • NCT03133546
54%
Diarrhea
49%
Proteinuria
43%
Fatigue
42%
Hypertension
41%
Cough
36%
Rash acneiform
32%
Anorexia
29%
Pain
25%
Constipation
25%
Mucositis oral
24%
Headache
22%
Nausea
22%
Vomiting
21%
Epistaxis
21%
Dry skin
21%
Upper respiratory infection
20%
Platelet count decreased
17%
Dyspnea
17%
Paronychia
16%
Lipase increased
16%
Serum amylase increased
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Electrocardiogram QT corrected interval prolonged
13%
Back pain
13%
Edema limbs
12%
Ejection fraction decreased
12%
Non-cardiac chest pain
12%
Dizziness
11%
Pruritus
9%
Abdominal pain
9%
Neutrophil count decreased
9%
Creatinine increased
9%
Sore throat
9%
Anemia
8%
Alkaline phosphatase increased
8%
GGT increased
8%
Rash maculo-papular
8%
Urinary tract infection
8%
Fever
8%
Hyponatremia
8%
Flu like symptoms
7%
White blood cell decreased
7%
Arthralgia
5%
Lung infection
5%
Dry eye
5%
Blurred vision
5%
Myalgia
4%
Drug overdose
4%
Atrial fibrillation
4%
Pleural effusion
4%
Pain in extremity
4%
Hypokalemia
3%
Thromboembolic event
3%
Heart failure
3%
Dry mouth
1%
Pneumonitis
1%
Bronchopulmonary hemorrhage
1%
Pneumothorax
1%
Hepatitis caused by COVID-19 infection
1%
Influenza
1%
Colitis
1%
Bronchial infection
1%
COVID-19 infection
1%
Enterocolitis infectious
1%
Influenza A
1%
Pleural infection
1%
Seizure
1%
Depressed level of consciousness
1%
Ischemia cerebrovascular
1%
Fracture
1%
Osteonecrosis of jaw
1%
Hypoglycemia
1%
Acute kidney injury
1%
Anxiety
1%
Gastrointestinal pain
1%
Gastric perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib Plus Bevacizumab
Osimertinib Alone

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Osimertinib with CarotuximabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Find a Location

Closest Location:Cedars-Sinai Medical Center· Los Angeles, CA· 1177 miles

Who is running the clinical trial?

Karen Reckamp, MD, MSLead Sponsor
Enviro Therapeutics, Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Carotuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401110 — Phase 1
~32 spots leftby Jan 2027
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